FDA Device recall Z-2114-2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG an…
- 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 104-36-XX, MCS +5GXL Liner 5/15 DEG an… 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-2114-2021 |
| 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 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. 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: 10885862013682, 10885862013699, 10885862013705, 10885862013712, 10885862013729 |
|---|
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-2114-2021%22
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