FDA Medical Device Recalls (openFDA)
Surgical Specialties Puerto Rico, Inc.: 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 number
- Z-0918-03
- Recalling firm
- Surgical Specialties Puerto Rico, Inc.
- Product
- 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***''
- Status
- Terminated
- Initiated
- 2003-05-07
- Posted
- 2003-06-05
- Terminated
- 2004-02-09
- Reason
- Incorrect handle was used in the manufacture of product 52-2761
- Root cause
- Other
- Action
- On 5/7/03 the cusotmers were notified of the recall via fax.
- Quantity
- 3,420 pieces
- Distribution
- Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts.
- Lot, serial or model codes
- Model number: 52-2761 Lot/Serial # Exp. Date M262530 2/2008 M262540 3/2008 M262550 3/2008
- 510(k) numbers
- ["K822112"]
- PMA numbers
- not on file
- Product code
- HNN
- Firm FEI
- 3008845715
- Firm city
- Rincon
- Firm state
- not on file
- Firm country
- PR
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28