CLASS II ONGOING Device recall · Reported 28 Jul 2021 · FDA Enforcement Report
Connexion GXL acetabular polyethylene liners used recalled by Exactech
Exactech is recalling Exactech Connexion GXL acetabular polyethylene liners used in the following systems, distributed nationwide in the US. The recall was initiated on 29 Jun 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2121-2021
- FDA event ID
- 88126
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jun 2021
- FDA classified
- 22 Jul 2021
- Reported
- 28 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 29 Jun 2021 | Recall initiated by company | |
| 22 Jul 2021 | Classified by FDA | +23 days |
| 28 Jul 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Product as listed by the FDA
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant component.
Where it was distributed
Distribution US nationwide.
Questions about this recall
Is Connexion GXL acetabular polyethylene liners used in the following systems recalled?
Yes. Exactech recalled Connexion GXL acetabular polyethylene liners used in the following systems on 29 Jun 2021. The recall is Class II and its status is Ongoing. Recall number Z-2121-2021.
Why was it recalled?
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Which lots are affected?
All serial numbers. UDI-DI numbers: 10885862023063, 10885862023070, 10885862023087, 10885862023094, 10885862023100, 10885862023117, 10885862023124, 10885862023148, 10885862023155, 10885862023162, 10885862303387, 10885862303394, 10885862303400
Where was it sold?
Distribution US nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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