Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396
FDA device recall Z-0093-2011 · posted 2010-10-20 · Terminated
Recall details
- Recalling firm
- Codman & Shurtleff, Inc.
- Reason for recall
- Surgical Pattie x-ray stripe (radio-opaque marker) became detached
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HBA
- Quantity affected
- 673 boxes (20 pouches of 10 patties per box)
- Distribution
- Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
- Date initiated
- 2010-07-16
- Date posted
- 2010-10-20
- Date terminated
- 2012-07-09
- Location
- Raynham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CODMAN SURGICAL PATTIE (K880402) | Codman & Shurtleff, Inc. | 1988-03-02 |