FDA Recall
Terminated
2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***''
Recall: Z-0918-03
·
Initiated May 7, 2003
Recall
- Recall Number
- Z-0918-03
- Event Number
- 26317
- Firm
- Surgical Specialties Puerto Rico, Inc. Road
- FEI Number
- 3008845715
- Product Code
- HNN
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 7, 2003
- Posted
- June 5, 2003
- Terminated
- February 9, 2004
- Address
- 115 Km.12.9, Rincon, PR, 00677
Description
2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***''
Reason
Incorrect handle was used in the manufacture of product 52-2761
Action
On 5/7/03 the cusotmers were notified of the recall via fax.
Distribution
Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts.
Quantity
3,420 pieces