Recall Z-0383-2024 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Biomet, Inc.
Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562
| Date | Nov 21, 2023 (initiated Oct 9, 2023) |
| Status | Open, Classified |
| Reason | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery |
| Root cause | Device Design |
| Action | Zimmer Biomet issued Urgent Medical Device Recall letter on 10/09/23 to Distributors and Risk Managers via email/courier . Letter states reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety no |
| Distribution | Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062998 | COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) Biomet Manufacturing Corp, Jan 19, 2007 |