NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native
FDA device recall Z-1376-2013 · posted 2013-05-24 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.
- Action taken
- Zimmer sent an "URGENT MEDICAL DEVICE RECALL LETTER" dated April 19, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HTW
- Quantity affected
- 69 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-03-27
- Date posted
- 2013-05-24
- Date terminated
- 2017-01-26
- 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 |
|---|---|---|
| NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 (K020295) | Implex Corp. | 2002-02-12 |
| THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 (K012866) | Implex Corp. | 2001-09-26 |