Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No.
FDA device recall Z-0985-03 · posted 2003-07-08 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery
- Reason for recall
- The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
- Action taken
- The firm contacted their customers by FedEx on 5/21/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDM
- Quantity affected
- 8 units
- Distribution
- The product was shipped to hospitals and distributors located nationwide.
- Date initiated
- 2003-05-21
- Date posted
- 2003-07-08
- Date terminated
- 2003-12-10
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS (K020779) | Ethicon Endo-Surgery, Inc. | 2002-06-05 |