Recall Z-0095-2011 ยท HBA Neurosurgical Paddie
Codman & Shurtleff, Inc.
Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403
| Date | Oct 20, 2010 (initiated Jul 16, 2010) |
| Status | Terminated |
| Reason | Surgical Pattie x-ray stripe (radio-opaque marker) may become detached |
| Root cause | Process control |
| Action | Codman notified customers by letter dated 7/16/10 issued July 23 through July 26, 2010 via Fed'x overnight advising users that the x-ray marker on Codman Surgical Patties may become detached. Customers are instructed to return product from affected lots. An error in the original letter was discovered and a corrected letter dated July 28, 2010 issued. If there are any questions, please contact Codman at (800) 225-0460. |
| Quantity | 229 boxes (100 cards/10 patties each card) |
| Distribution | Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880402 | CODMAN SURGICAL PATTIE Codman & Shurtleff, Inc., Mar 2, 1988 |