FDA Medical Device Recalls (openFDA)
SSC- Surgical Specialties Corporation: Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
- Recall number
- Z-2042-2016
- Recalling firm
- SSC- Surgical Specialties Corporation
- Product
- Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
- Status
- Terminated
- Initiated
- 2016-05-20
- Posted
- not on file
- Terminated
- 2016-08-12
- Reason
- Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.
- Root cause
- Process control
- Action
- A customer notification letter dated 5/20/16 was sent to all customers to inform them that Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture. Customers are instructed to complete the attached customer acknowledgement form and return via fax to Surgical Specialties' Quality Assurance department at (610) 404-4010 or return via email to kknappenberger@surgicalspecialties.com. Customers with any questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.
- Quantity
- 36 boxes (432 units)
- Distribution
- TX, ME, MA, MI, OH, KS, MN, KS, TN, GA
- Lot, serial or model codes
- MAPX540
- 510(k) numbers
- ["K904906"]
- PMA numbers
- not on file
- Product code
- GAW
- Firm FEI
- 3011767135
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
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