Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GX
FDA device recall Z-2114-2021 · posted 2021-07-22 · Open, Classified
Recall details
- Recalling firm
- Exactech, Inc.
- 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.
- 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.
- Root cause
- Unknown/Undetermined by firm
- Status
- Open, Classified
- Product code
- LPH
- Quantity affected
- 89,050 total
- Distribution
- Distribution US nationwide.
- Date initiated
- 2021-06-29
- Date posted
- 2021-07-22
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE (K051556) | Exactech, Inc. | 2005-09-06 |