fbpx

US Exactech Recall Information

Important Patient Information Regarding the Equinoxe Shoulder System

This is an informational notice about Equinoxe Shoulder polyethylene humeral liners and anatomic glenoids that were packaged in nonconforming bags.

We are conducting a voluntary medical device recall for nonconforming packaging in order to retrieve unused inventory. If a patient has a shoulder component within the scope of this recall, this does not mean that the shoulder component needs to be replaced.

If you are experiencing any new or worsening pain or swelling, inability to use your arm, grinding or other noise, or weakness around your implanted device, you should contact your health care provider for further investigation of the cause of the new or worsening symptoms, which could include implant factors as well as patient factors (age, sex, physical characteristics, activity level, etc.), surgical factors (technique, alignment, etc.), and postoperative rehabilitative factors. Normal patient monitoring and follow-up per your surgeon’s standard of care is recommended. Revisions of well performing shoulders from nonconforming packaging are not recommended.

If you would like to read the full FDA communication, <click here>. An excerpt is below:

“Recommendations for Patients:

    • If your Equinoxe Shoulder System is functioning well and you have no pain or symptoms, the FDA does not recommend surgery to remove a well-functioning device.
    • Contact your health care provider if you have an Equinoxe Shoulder System implanted and you are experiencing any new or worsening pain or swelling, inability to use your arm, grinding or other noise, or weakness around your implanted device.”

You can look up your information here to learn if an implant that was packaged in nonconforming packaging was used during your procedure. Please use the following link to see if your shoulder liner is affected by this recall (you will need your serial number):

The following products are affected:

Scroll right to view the full table on mobile devices.

Product Line DescriptionTotal Affected Units Sold (US)
(2004-2.15.2024)
Equinoxe aTSA Devices
314-01-0XEQUINOXE GLENOID, KEELED ALPHA854
314-01-1XEQUINOXE GLENOID, KEELED BETA989
314-02-0XEQUINOXE GLENOID, PEGGED ALPHA4054
314-02-1XEQUINOXE GLENOID, PEGGED BETA5035
314-02-2XEQUINOXE POST AUG GLENOID, LEFT527
314-02-3XEQUINOXE POST AUG GLENOID, RIGHT672
314-04-2XEQUINOXE POST AUG GLENOID, LEFT 1237
314-04-3XEQUINOXE POST AUG GLENOID, RIGHT, 1241
314-06-2XEQUINOXE POST AUG GLENOID, LEFT, 16131
314-06-3XEQUINOXE POST AUG GLENOID, RIGHT, 16193
314-13-0XEQUINOXE CAGE GLENOID, ALPHA10306
314-13-1XEQUINOXE CAGE GLENOID, BETA12434
314-13-2XEQUINOXE CAGE GLENOID, POST AUG, LEFT3209
314-13-3XEQUINOXE CAGE GLENOID, POST AUG, RIGHT3731
Equinoxe rTSA Devices
320-36-0XEQUINOXE 145-DEG PE 36MM HUM LINER9434
320-36-1XEQUINOXE 145-DEG PE 36MM CONST HUM LINER803
320-38-0XEQUINOXE 145-DEG PE 38MM HUM LINER41398
320-38-1XEQUINOXE 145-DEG PE 38MM CONST HUM LINER3225
320-40-0XEQUINOXE 145-DEG PE 40MM HUM LINER2826
320-40-1XEQUINOXE 145-DEG PE 40MM CONST HUM LINER437
320-42-0XEQUINOXE 145-DEG PE 42MM HUM LINER19262
320-42-1XEQUINOXE 145-DEG PE 42MM CONST HUM LINER2354
320-46-0XEQUINOXE 145-DEG PE 46MM HUM LINER1839
320-46-1XEQUINOXE 145-DEG PE 46MM CONST HUM LINER440

More about the Equinoxe® Shoulder System:

The platform system allows conversion of a primary or fracture shoulder replacement to a reverse without the need to remove the already well-fixed stem. The high-quality implants are designed to:

  • Help match each individual patient’s bone structure
  • Preserve a patient’s natural anatomy
  • Work in a variety of procedures
  • Address unique clinical challenges
Exactech Equinoxe Anatomic Shoulder Replacement
Anatomic System
Reverse System

To learn more about your implant, click here

Knee and Ankle Polyethylene

This is to inform you of recent observations made by Exactech regarding the clinical performance of our Knee and Ankle polyethylene inserts.

The following products are affected:

Scroll right to view the full table on mobile devices.

Product LineSpecific Brand NameTotal Units Sold
Globally
(2004-2.22.2022)
OPTETRAK® All-polyethylene Tibial Components (TKR)5078
200-11-XXOPTETRAK® All-polyethylene CR Tibial Components1
200-12-XXOPTETRAK® All-polyethylene CR Tibial Components36
200-13-XXOPTETRAK® All-polyethylene CR Tibial Components117
200-14-XXOPTETRAK® All-polyethylene CR Tibial Components79
200-15-XXOPTETRAK® All-polyethylene CR Tibial Components38
200-16-XXOPTETRAK® All-polyethylene CR Tibial Components8
204-11-XXOPTETRAK® All-polyethylene PS Tibial Components1097
204-12-XXOPTETRAK® All-polyethylene PS Tibial Components1834
204-13-XXOPTETRAK® All-polyethylene PS Tibial Components1277
204-14-XXOPTETRAK® All-polyethylene PS Tibial Components528
204-15-XXOPTETRAK® All-polyethylene PS Tibial Components61
204-16-XXOPTETRAK® All-polyethylene PS Tibial Components2
OPTETRAK® All-polyethylene Tibial Components (PKR)3428
252-12-XXOPTETRAK® All-polyethylene UNI Tibial Components1163
252-13-XXOPTETRAK® All-polyethylene UNI Tibial Components1198
252-22-XXOPTETRAK® All-polyethylene UNI Tibial Components524
252-23-XXOPTETRAK® All-polyethylene UNI Tibial Components543
OPTETRAK® Tibial Inserts (TKR)218944
200-21-XXOPTETRAK® CR TIBIAL INSERT5803
200-22-XXOPTETRAK® CR TIBIAL INSERT24356
200-23-XXOPTETRAK® CR TIBIAL INSERT20527
200-24-XXOPTETRAK® CR TIBIAL INSERT9570
200-25-XXOPTETRAK® CR TIBIAL INSERT3032
200-26-XXOPTETRAK® CR TIBIAL INSERT270
200-50-XXOPTETRAK® CR TIBIAL INSERT161
200-51-XXOPTETRAK® CR TIBIAL INSERT4102
200-56-XXOPTETRAK® CR TIBIAL SLOPE + INSERT67
200-57-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT93
200-61-XXOPTETRAK® CR TIBIAL SLOPE + INSERT176
200-62-XXOPTETRAK® CR TIBIAL SLOPE + INSERT1012
200-63-XXOPTETRAK® CR TIBIAL SLOPE + INSERT1047
200-64-XXOPTETRAK® CR TIBIAL SLOPE + INSERT623
200-65-XXOPTETRAK® CR TIBIAL SLOPE + INSERT204
200-71-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT148
200-72-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT906
200-73-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT1030
200-74-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT563
200-75-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT218
204-21-XXOPTETRAK® PS TIBIAL INSERTS10048
204-22-XXOPTETRAK® PS TIBIAL INSERTS38886
204-23-XXOPTETRAK® PS TIBIAL INSERTS32689
204-24-XXOPTETRAK® PS TIBIAL INSERTS14623
204-25-XXOPTETRAK® PS TIBIAL INSERTS4748
204-26-XXOPTETRAK® PS TIBIAL INSERTS611
204-50-XXOPTETRAK® PS TIBIAL INSERTS392
204-51-XXOPTETRAK® PS TIBIAL INSERTS5516
204-91-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT282
204-92-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT864
204-93-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT1167
204-94-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT668
204-95-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT176
208-21-XXOPTETRAK® CC TIBIAL INSERT2996
208-22-XXOPTETRAK® CC TIBIAL INSERT10026
208-23-XXOPTETRAK® CC TIBIAL INSERT9143
208-24-XXOPTETRAK® CC TIBIAL INSERT5175
208-25-XXOPTETRAK® CC TIBIAL INSERT1824
208-51-XXOPTETRAK® CC TIBIAL INSERT1136
224-21-XXOPTETRAK® B-SERIES PS TIBIAL INSERT547
224-22-XXOPTETRAK® B-SERIES PS TIBIAL INSERT1719
224-23-XXOPTETRAK® B-SERIES PS TIBIAL INSERT1347
224-24-XXOPTETRAK® B-SERIES PS TIBIAL INSERT453
OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR)51913
244-20-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts226
244-21-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts6787
244-22-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts18921
244-23-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts15578
244-24-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts7662
244-25-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts2739
ARTHROFOCUS® Polyethylene Tibial Inserts (TKR)12
256-12-XXARTHROFOCUS® Polyethylene Tibial Inserts6
256-13-XXARTHROFOCUS® Polyethylene Tibial Inserts6
OPTETRAK® Custom Polyethylene Tibial Inserts (TKR)41
900-06-XXCUSTOM OPTETRAK® ANGLED PS INSERT6
900-08-XXCUSTOM OPTETRAK® ANGLED PS INSERT6
900-23-XXCUSTOM OPTETRAK® CC TIBIAL INSERT21
900-30-XXCUSTOM OPTETRAK® CC TIBIAL INSERT4
900-33-XXCUSTOM OPTETRAK® CC INSERT4
OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR)127998
02-012-35-XXXXOPTETRAK® Logic PS Tibial Inserts80506
02-012-44-XXXXOPTETRAK® Logic PSC Tibial Inserts19323
02-012-47-XXXXOPTETRAK® Logic CR Tibial Inserts9139
02-012-48-XXXXOPTETRAK® Logic CR Slope + Tibial Inserts3083
02-012-49-XXXXOPTETRAK® Logic CR Slope ++ Tibial Inserts2853
02-012-51-XXXXOPTETRAK® Logic CRC Tibial Inserts10291
02-012-65-XXXXOPTETRAK® Logic CC Tibial Inserts2803
OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR)33393
264-21-XXOPTETRAK® RBK PS Tibial Components2938
264-22-XXOPTETRAK® RBK PS Tibial Components10994
264-23-XXOPTETRAK® RBK PS Tibial Components11560
264-24-XXOPTETRAK® RBK PS Tibial Components5738
264-25-XXOPTETRAK® RBK PS Tibial Components2163
TRULIANT® Tibial Inserts (TKR)38075
02-022-35-XXXXTRULIANT® PS Tibial Inserts20913
02-022-44-XXXXTRULIANT® PSC Tibial Inserts6519
02-022-47-XXXXTRULIANT® CR Tibial Inserts3095
02-022-48-XXXXTRULIANT® CR Slope + Tibial Inserts504
02-022-49-XXXXTRULIANT® CR Slope ++ Tibial Inserts335
02-022-51-XXXXTRULIANT® CRC Tibial Inserts6709
OPTETRAK® Logic RBK Tibial Components (TKR)10616
02-012-38-XXXXOPTETRAK® Logic RBK PS Tibial Components10616
Vantage® Fixed-Bearing Polyethylene Liner Component (TAR)2959
350-21-XXVantage® Fixed-Bearing Polyethylene Liner Component1422
350-22-XXVantage® Fixed-Bearing Polyethylene Liner Component1537
Vantage® Mobile-Bearing Polyethylene Liner Component (TAR)761
350-41-XXVantage® Mobile-Bearing Polyethylene Liner Component352
350-42-XXVantage® Mobile-Bearing Polyethylene Liner Component409

Exactech Knee & Ankle Polyethylene Patients: What to do

Please use the following link to see if your hip liner is affected by this recall (you will need your serial number):

Connexion GXL & Conventional Hip Liners

This is to inform you of recent observations made by Exactech regarding the clinical performance of Connexion GXL and conventional polyethylene acetabular liners sold in the United States. The product-specific information is listed in the links below.
The following products are affected:

Scroll right to view the full table on mobile devices.

Product Line NumberProduct Line DescriptionTotal Affected Devices Distributed
(US)
Acumatch GXL Acetabular Liners
130-28-2XACUMATCH GXL 0 DEGREE 28MM ACETABULAR LINER61
130-32-2XACUMATCH GXL 0 DEGREE 32MM ACETABULAR LINER154
130-36-2XACUMATCH GXL 0 DEGREE 36MM ACETABULAR LINER125
132-28-2XACUMATCH GXL 15 DEGREE 28MM ACETABULAR LINER800
132-28-3XACUMATCH GXL 15 DEGREE 28MM ACETABULAR LINER1
132-32-2XACUMATCH GXL 15 DEGREE 32MM ACETABULAR LINER1747
132-32-3XACUMATCH GXL 15 DEGREE 32MM ACETABULAR LINER6
132-36-2XACUMATCH GXL 15DEG LINER 36MM1144
132-36-3XACUMATCH GXL 15DEG LINER 36MM5
134-28-2XACUMATCH GXL 28MM EXTENDED COVERAGE LINER151
134-28-3xACUMATCH GXL 28MM EXTENDED COVERAGE LINER1
138-28-2XACUMATCH GXL 15 DEGREE +5 LATERALIZED 28MM ACETABULAR LINER84
138-36-27ACUMATCH GXL 15 DEGREE +5 LATERALIZED 38MM ACETABULAR LINER1
138-39-28ACUMATCH GXL 15 DEGREE +5 LATERALIZED 36MM ACETABULAR LINER97
138-36-29ACUMATCH GXL 15 DEGREE +5 LATERALIZED 36MM ACETABULAR LINER45
MCS GXL Acetabular Liners
104-28-4XMCS GXL 5/15 DEGREE 28MM ACETABULAR LINER92
104-32-XXMCS GXL 5/15 DEGREE 32MM ACETABULAR LINER114
104-36-XXMCS GXL 5/15 DEGREE 36MM ACETABULAR LINER24
900-02-1XMCS CUSTOM GXL ACETABULAR LINER6
900-02-5XMCS CUSTOM GXL ACETABULAR LINER2
Novation GXL Acetabular Liners
130-28-5XNOVATION GXL NEUTRAL 28MM ACETABULAR LINER1434
130-32-5XNOVATION GXL NEUTRAL 32MM ACETABULAR LINER6679
130-36-5XNOVATION GXL NEUTRAL 36MM ACETABULAR LINER9806
130-40-XXNOVATION GXL NEUTRAL 40MM ACETABULAR LINER754
132-28-5XNOVATION GXL LIPPED 28MM ACETABULAR LINER812
132-32-5XNOVATION GXL LIPPED 32MM ACETABULAR LINER4188
132-32-6XNOVATION GXL LIPPED ANTERIOR 32MM ACETABULAR LINER21
132-36-5XNOVATION GXL LIPPED 36MM ACETABULAR LINER4694
132-36-6XNOVATION GXL LIPPED ANTERIOR 36MM ACETABULAR LINER15
132-40-XXNOVATION GXL LIPPED 40MM ACETABULAR LINER688
136-28-XXNOVATION GXL +5 LATERALIZED 28MM ACETABULAR LINER9
136-32-XXNOVATION GXL +5 LATERALIZED 32MM ACETABULAR LINER413
136-36-XXNOVATION GXL +5 LATERALIZED 36MM ACETABULAR LINER2268
136-40-XXNOVATION GXL +5 LATERALIZED 40MM ACETABULAR LINER175
138-32-XXNOVATION GXL 10° FACE CHANGING 32MM ACETABULAR LINER413
138-36-5XNOVATION GXL 10° FACE CHANGING 36MM ACETABULAR LINER1172
138-40-XXNOVATION GXL 10° FACE CHANGING 40MM ACETABULAR LINER110
Exactech All Polyethylene Cemented Acetabular Cup
106-22-XXALL POLY CEMENTED CUP 22MM15
106-28-XXALL POLY CEMENTED CUP 28MM14
106-32-XXALL POLY CEMENTED CUP 32MM8
Acumatch Conventional UHMWPE
130-28-XXACUMATCH 0 DEGREE ACETABULARLINER 28MM8
132-22-XXACUMATCH 15 DEGREE ACETABULAR LINER 22MM1
132-28-XXACUMATCH 15 DEGREE ACETABULAR LINER 28MM246
132-32-XXACUMATCH 15 DEGREE ACETABULAR LINER 32MM657
132-36-XXACUMATCH 15 DEGREE ACETABULAR LINER 36MM121
134-28-XXACUMATCH EXTENDED COVERAGE ACETABULARLINER 28MM14
138-28-XXACUMATCH LATERALIZED ACETABULAR LINER 28MM8
138-36-XXACUMATCH +5MM LATERALIZED ACETABULARLINER 15 DEG 36MM7
144-28-XXACUMATCH 0 DEGREE CONSTRAINED ACETABULAR LINER 28MM29
144-32-XXACUMATCH 0 DEGREE CONSTRAINED ACETABULARLINER 32MM133
MCS Conventional UHMWPE
146-28-XXMCS 0 DEGREE CONSTRAINED ACETABULAR LINER 28 MM16
146-32-XXMCS 0 DEGREE CONSTRAINED ACETABULAR LINER 32 MM7
900-01-93CUSTOM MCS ACETABULAR LINER +0 22MM2
900-01-94CUSTOM MCS ACETABULAR LINER +5 LATERALIZED 22MM3
MCS Conventional UHMWPE
134-28-4XNOVATION CONSTRAINED ACETABULAR LINER 28MM83
134-32-XXNOVATION CONSTRAINED ACETABULAR LINER 32MM187
134-36-XXNOVATION CONSTRAINED ACETABULAR LINER 36MM232

Exactech Hip Polyethylene Patients: What to do

Please use the following link to see if your hip liner is affected by this recall (you will need your serial number):