Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an indivi
FDA device recall Z-0026-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Surgical Specialties Corp
- Reason for recall
- text on product handle is incorrect
- Action taken
- The consignees were notified via fax on 8/21/03. One customer received a recall letter via mail on 8/22/03.
- Root cause
- Other
- Status
- Terminated
- Product code
- HNN
- Quantity affected
- 666 units
- Distribution
- The products were shipped to two hospitals in CA, two sales representatives in NC & IL, and three wholesalers in IL, Belgium, Canada, and Austrailia.
- Date initiated
- 2003-08-21
- Date posted
- 2003-10-15
- Date terminated
- 2004-01-13
- Location
- Reading, PA
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 |