Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.
FDA device recall Z-0705-03 · posted 2003-04-01 · Terminated
Recall details
- Recalling firm
- Surgical Specialties Corp
- Reason for recall
- size mislabeled on product handle
- Action taken
- On 1/7/03, one account was contacted via telephone. On 1/10/03, a recall letter was faxed to that account. On 3/11/03, this wholesale account was asked to contact a hospital sub account that received a direct shipment. The other account was the complainant and telephone communications were occurring.
- Root cause
- Other
- Status
- Terminated
- Product code
- HNN
- Quantity affected
- 635 units
- Distribution
- The product was shipped to 2 wholesale accounts in PA and LA.
- Date initiated
- 2003-01-07
- Date posted
- 2003-04-01
- Date terminated
- 2003-03-31
- 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 |