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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Exactech AcuMatch, Novation, and Alteon Hip Liners Recalled for Packaging Defect

Agency Publication Date: February 12, 2025
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Summary

Exactech, Inc. is recalling approximately 1,575 hip liners sold under the AcuMatch XLE, Novation XLE, and Alteon XLE brand names. These surgical implants were packaged without a necessary Ethylene Vinyl Alcohol (EVOH) barrier layer, which is intended to protect the plastic from oxygen. Without this barrier, the liners can undergo oxidation, causing the material to degrade and potentially fail earlier than expected. The recall affects medical devices distributed to hospitals and surgical centers across multiple states and international locations.

Risk

The lack of a proper oxygen barrier causes the polyethylene liners to oxidize, which can lead to accelerated wear and debris in the hip joint. This degradation can cause bone loss (osteolysis) and eventual implant failure, which may require complex revision surgery to correct.

What You Should Do

  1. This recall affects AcuMatch XLE, Novation XLE, and Alteon XLE Hip Liners used in hip replacement surgeries.
  2. Healthcare facilities and surgeons should check their current inventory for the specific item numbers and serial numbers associated with these hip systems. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately and quarantine any remaining stock to prevent further implantation.
  4. Contact the manufacturer, Exactech, Inc., or your distributor to arrange for the return, replacement, or correction of any affected units in your possession.
  5. For patients already implanted with these devices, healthcare providers should follow established clinical protocols for monitoring hip replacement patients.
  6. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report any adverse events related to these devices.

Your Remedy Options

📋Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: AcuMatch XLE Hip Liners
Model / REF:
140-28-27
140-32-27
140-32-28
140-28-29
140-32-29
140-36-29
140-32-30
140-36-30
140-28-25
140-28-26
140-28-28
140-36-28
140-28-30
142-28-24
142-28-26
142-32-27
142-32-28
142-36-28
142-36-29
142-28-29
142-32-29
142-28-30
142-32-30
142-36-30
142-28-25
142-28-27
142-28-28
144-28-28
144-28-29
144-28-25
144-28-26
144-28-27
144-28-30
148-28-26
148-28-27
148-36-28
148-36-29
148-28-30
148-36-30
148-28-25
148-28-28
148-28-29
UDI:
10885862537997
10885862538031
10885862538048
10885862538017
10885862538055
10885862538086
10885862538062
10885862538093
10885862537973
10885862537980
10885862538000
10885862538079
10885862538024
10885862538123
10885862538147
10885862538192
10885862538208
10885862538239
10885862538246
10885862538178
10885862538215
10885862538185
10885862538222
10885862538253
10885862538130
10885862538154
10885862538161
10885862538291
10885862538307
10885862538260
10885862538277
10885862538284
10885862538314
10885862538338
10885862538345
10885862538383
10885862538390
10885862538376
10885862538406
10885862538321
10885862538352
10885862538369

Affected quantity: 42 units.

Product: Novation XLE Hip Liners
Model / REF (70):
140-22-70
140-28-50
140-28-51
140-28-52
140-32-51
140-32-52
140-32-53
140-32-54
140-32-55
140-36-52
140-36-53
140-36-54
140-36-55
140-40-53
140-40-54
140-40-55
142-22-68
142-22-70
142-28-50
142-28-51
142-28-52
142-28-60
142-28-61
142-28-62
142-32-51
142-32-52
142-32-53
142-32-54
142-32-55
142-32-61
142-32-62
142-32-63
142-32-64
142-32-65
142-36-52
142-36-53
142-36-54
142-36-55
142-36-62
142-36-63
142-36-64
142-36-65
142-40-53
142-40-54
142-40-55
142-40-63
142-40-64
142-40-65
146-22-70
146-28-51
Serial Numbers (87):
6594943
6970850
6595376
6595380
6858220
6858230
6973123
6594924
6970840
6595383
6595385
6595381
6970835
6970838
6970842
6595922
6510276
6973139
6558356
6422337
6631675
6504196
6631677
6631695
6631712
6844304
6631689
6631699
6631725
6558360
6844285
6844298
6844281
6348961
6504177
6504195
6504202
6504204
6631686
6844321
6600076
6600101
6600054
6600057
6600093
6510314
6510327
7040076
6842549
6554448
UDI (70):
10885862537225
10885862537232
10885862537249
10885862537256
10885862537263
10885862537270
10885862537287
10885862537294
10885862537300
10885862537317
10885862537324
10885862537331
10885862537348
10885862537355
10885862537362
10885862537379
10885862537546
10885862537386
10885862537393
10885862537409
10885862537416
10885862537553
10885862537560
10885862537577
10885862537423
10885862537430
10885862537447
10885862537454
10885862537461
10885862537584
10885862537591
10885862537607
10885862537614
10885862537621
10885862537478
10885862537485
10885862537492
10885862537508
10885862537638
10885862537645
10885862537652
10885862537669
10885862537515
10885862537522
10885862537539
10885862537676
10885862537683
10885862537690
10885862537751
10885862537768

Affected quantity: 87 units.

Product: Alteon XLE Hip Liners
Model / REF (84):
01-030-40-0022
01-030-40-0122
01-030-40-0128
01-030-40-0222
01-030-40-0228
01-030-40-0232
01-030-40-0322
01-030-40-0328
01-030-40-0332
01-030-40-0422
01-030-40-0428
01-030-40-0432
01-030-40-0436
01-030-40-0522
01-030-40-0528
01-030-40-0532
01-030-40-0536
01-030-40-0622
01-030-40-0628
01-030-40-0632
01-030-40-0636
01-030-40-0640
01-030-40-0722
01-030-40-0728
01-030-40-0732
01-030-40-0736
01-030-40-0740
01-030-40-0822
01-030-40-0828
01-030-40-0832
01-030-40-0836
01-030-40-0840
01-030-42-0128
01-030-42-0228
01-030-42-0232
01-030-42-0328
01-030-42-0332
01-030-42-0428
01-030-42-0432
01-030-42-0436
01-030-42-0528
01-030-42-0532
01-030-42-0536
01-030-42-0628
01-030-42-0632
01-030-42-0636
01-030-42-0640
01-030-42-0728
01-030-42-0732
01-030-42-0736
Serial Numbers (888):
6771453
6771460
6771467
6771484
6771458
6771456
6771468
6771479
6771444
6771461
6771470
6771474
6771481
6515426
6515434
6750140
6750151
6597399
6597410
6750127
6750132
6750145
6906249
6515440
6597407
6597409
6515443
6597398
6597408
6515428
6750152
6597400
6515441
6515442
6597403
6750164
6906241
6906245
6906258
6532932
6532935
6904616
6436003
6486043
6512970
6512972
6592041
6592052
6838572
6838573
UDI (83):
10885862549433
10885862549440
10885862549457
10885862549464
10885862549471
10885862549488
10885862549495
10885862549501
10885862549518
10885862549532
10885862549549
10885862549556
10885862549563
10885862549570
10885862549587
10885862549594
10885862549600
10885862549624
10885862549631
10885862549648
10885862549655
10885862549662
10885862549679
10885862549686
10885862549693
10885862549709
10885862549716
10885862549723
10885862549730
10885862549747
10885862549754
10885862549761
10885862549792
10885862549815
10885862549822
10885862549846
10885862549853
10885862549884
10885862549891
10885862549907
10885862549921
10885862549938
10885862549945
10885862549976
10885862549983
10885862549990
10885862550002
10885862550026
10885862550033
10885862550040

Affected quantity: 1,446 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96102
Status: Active
Manufacturer: Exactech, Inc.
Sold By: hospitals; surgical centers; orthopedic clinics
Manufactured In: United States
Units Affected: 3 products (42; 87; 1446)
Distributed To: Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.