Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 S
FDA device recall Z-1192-2018 · posted 2018-03-14 · Terminated
Recall details
- Recalling firm
- Zimmer Biomet, Inc.
- Reason for recall
- Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
- Action taken
- RISK MANAGER: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. DISTRIBUTOR: 1. Review this notification and notify affected team members of the contents. 2. Quarantine affected product in your inventory. 3. Return affected product from your distributorship and from affected hospitals. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 24
- Distribution
- Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
- Date initiated
- 2018-03-01
- Date posted
- 2018-03-14
- Date terminated
- 2019-07-18
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER M/L TAPER HIP PROSTHESIS (K060040) | Zimmer, Inc. | 2006-05-12 |