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.
This recall is currently active, issued July 22, 2021. It was issued by Exactech, Inc..
- Company
- Exactech, Inc.
- Recall Initiated
- June 29, 2021
- Posted
- July 22, 2021
- Recall Number
- Z-2114-2021
- Quantity
- 89,050 total
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Distribution US nationwide.
Lot / Code Info
All serial numbers. UDI-DI numbers: 10885862013682, 10885862013699, 10885862013705, 10885862013712, 10885862013729
Root Cause
Unknown/Undetermined by firm
Action Taken
The firm issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 6/28/2021 via email on 6/29/2021 that were addressed to the attention of Exactech Agents, Representatives, and Distributors in possession of affected products.
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