FDA Medical Device Recalls (openFDA)
Surgical Specialties Puerto Rico, Inc.: Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full handled. 54-1031, Sharptome Crescent Knife, double bevel, angled, full handled
- Recall number
- Z-0949-04
- Recalling firm
- Surgical Specialties Puerto Rico, Inc.
- Product
- Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full handled. 54-1031, Sharptome Crescent Knife, double bevel, angled, full handled
- Status
- Terminated
- Initiated
- 2004-03-03
- Posted
- 2004-07-20
- Terminated
- 2004-09-10
- Reason
- Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
- Root cause
- Other
- Action
- Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.
- Quantity
- not on file
- Distribution
- Distribution was nationwide and internationally
- Lot, serial or model codes
- Model No. Lot # Exp. Date 54-1010 M316220 9/2008 54-1010 M316160 7/2008 54-1010 M316180 7/2008 54-1031 M365220 10/2008
- 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