2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Di
FDA device recall Z-0918-03 · posted 2003-06-05 · Terminated
Recall details
- Recalling firm
- Surgical Specialties Puerto Rico, Inc.
- Reason for recall
- Incorrect handle was used in the manufacture of product 52-2761
- Action taken
- On 5/7/03 the cusotmers were notified of the recall via fax.
- Root cause
- Other
- Status
- Terminated
- Product code
- HNN
- Quantity affected
- 3,420 pieces
- Distribution
- Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts.
- Date initiated
- 2003-05-07
- Date posted
- 2003-06-05
- Date terminated
- 2004-02-09
- 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 |