FDA Medical Device Recalls (openFDA)
Surgical Specialties Corp: 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
- Recall number
- Z-0034-2009
- Recalling firm
- Surgical Specialties Corp
- Product
- 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
- Status
- Terminated
- Initiated
- 2008-09-09
- Posted
- 2008-10-02
- Terminated
- 2009-03-27
- Reason
- mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture
- Root cause
- Employee error
- Action
- The recalling firm issued a Recall letter dated 9/9/08 to its customers. The letter informed the customers of the problem, the need to conduct a sub-recall, and return the product. Contact Surgical Specialties Corp. at 1-610-404-1000 for assistance.
- Quantity
- 956 boxes
- Distribution
- USA--AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MD, MI, MS, NC, NJ, NY, OH, TN, TX, VA, and WA. OUS: Australia, Canada, and Fiji Islands.
- Lot, serial or model codes
- Lot number M335870
- 510(k) numbers
- ["K930825"]
- PMA numbers
- not on file
- Product code
- GAR
- Firm FEI
- 2522801
- Firm city
- Reading
- Firm state
- PA
- 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