FDA Medical Device Recalls (openFDA)
Surgical Specialties Corp: Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed)
- Recall number
- Z-0936-04
- Recalling firm
- Surgical Specialties Corp
- Product
- Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed)
- Status
- Terminated
- Initiated
- 2003-08-25
- Posted
- 2004-07-20
- Terminated
- 2004-08-19
- Reason
- sterilization method incorrect
- Root cause
- Other
- Action
- The only customer was notified via email on 8/26/03 that the product was subject to a recall and needed to be returned.
- Quantity
- 2 boxes
- Distribution
- The product was shipped to a wholesaler in Japan.
- Lot, serial or model codes
- Model number DB513, Lot number M384030 exp. 7/08
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAT
- 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