Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw, Smith & Nephew, Endo
FDA device recall Z-0593-2008 · posted 2008-03-19 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
- Action taken
- Smith & Nephew issued an Urgent Product Recall letter via Federal Express to User Facilities, Sales Reps and Distributors on 8/21/07. A second letter was issued on 8/23/07 to correct two errors in model numbers listed in the original letter. Letter issued by FedEx and/or email to OUS contacts.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 2569 units
- Distribution
- Worldwide Distribution - USA, Austria. Belgium, Germany, Denmark, Spain, Finland, France, England, Italy, Portugal, Netherlands, Norway, New Zealand, Sweden, Turkey, Switzerland, China, Hong Kong, Mal
- Date initiated
- 2007-08-21
- Date posted
- 2008-03-19
- Date terminated
- 2012-05-09
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PLC SCREW (K051310) | Smith & Nephew, Inc. | 2005-07-26 |