Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, beve
FDA device recall Z-0946-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Surgical Specialties Puerto Rico, Inc.
- Reason for recall
- Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
- Action taken
- Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.
- Root cause
- Other
- Status
- Terminated
- Product code
- HNN
- Distribution
- Distribution was nationwide and internationally
- Date initiated
- 2004-03-03
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-10
- Location
- Rincon, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPHTHALMIC KNIFE (K822112) | Sharpoint, Inc. | 1982-08-10 |