Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 00, for cemented use only, sterile, Zimmer,
FDA device recall Z-1482-2009 · posted 2009-06-30 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The tibial spacer will not affix to the distal surface of the baseplate, as intended.
- Action taken
- Zimmer, Inc. issued an "Urgent-Device Recall" letter dated March 18, 2009 instructing users to cease using and return the affected product accompanied with a completed Inventory Return Certification form. The inventory Return Certification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. Further questions should be addressed to Zimmer, Inc. at 1-800-613-6131.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 834 of all products
- Distribution
- Worldwide Distribution - USA including states of CA, NY, MI, OH, WI, IA, MN, NJ, IL, MO, TX, LA, NC, SC, PA, AR, MS, FL, GA, AL, OK, KS, TN, CT, NM, UT, NV, ID and CO and Switzerland.
- Date initiated
- 2009-03-18
- Date posted
- 2009-06-30
- Date terminated
- 2009-10-23
- 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 |
|---|---|---|
| NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE (K023528) | Centerplus Orthopedics, Inc. | 2003-01-17 |