FDA Device recall Z-2117-2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner…
- FDA Device
- Class II
- ongoing
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner… by Exactech, citing risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2117-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-29 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exactech |
| Distribution | US |
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hip implant component.
Reason
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Identifiers
| code_info | All serial numbers. UDI-DI numbers: 10885862022097, 10885862022103, 10885862022110, 10885862022127, 10885862207074, 10…All serial numbers. UDI-DI numbers: 10885862022097, 10885862022103, 10885862022110, 10885862022127, 10885862207074, 10885862022165, 10885862022172, 10885862022189, 10885862022196 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2117-2021%22
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