Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems; Rx only Biomet Trauma, 100 Interp
FDA device recall Z-2115-2009 · posted 2009-09-21 · Terminated
Recall details
- Recalling firm
- EBI, L.P.
- Reason for recall
- Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
- Action taken
- Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 51
- Distribution
- Worldwide Distribution -- USA and Spain.
- Date initiated
- 2009-03-27
- Date posted
- 2009-09-21
- Date terminated
- 2009-09-23
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOMET FEMORAL LOCKING NAIL SYSTEM (K072161) | Biomet Manufacturing Corp | 2007-09-20 |