AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds,
FDA device recall Z-1643-2011 · posted 2011-03-22 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- The firm recieved a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressing through and penetrating the acetabulum.
- Action taken
- On 1/12/2011 DePuy contacted their distributors by telephone and directed the distributors to cancel all pending surgeries and discontinue use of the sets until the investigation is completed. On 1/14/2011 DePuy again contacted all distributors by telephone and directed all distributors to return the instruments to DePuy for inspection as part of the investigation.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 296 units
- Distribution
- Worldwide Distribution -- US, including the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, NV, NY, OH, PA, TN, TX, VA, WA, WI; and country of Switzerland.
- Date initiated
- 2011-01-12
- Date posted
- 2011-03-22
- Date terminated
- 2012-06-27
- 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 |
|---|---|---|
| HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM (K100238) | DePuy Orthopaedics, Inc. | 2010-05-11 |