Z-0936-04

Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white...

Name: Z-0936-04 Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white...
Creator: Surgical Specialties Corp
Published: 2003-08-25
License: https://open.fda.gov/license/

Surgical Specialties Corp / initiated 2003-08-25 / Terminated / root cause: sterility

FDA source

Surgical Specialties Corp began a recall of Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles... on 2003-08-25. The reason FDA records is "sterilization method incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0936-04
Status: Terminated
Initiated: 2003-08-25
Posted: 2004-07-20
Terminated: 2004-08-19
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)
Product code: GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Reason for recall: sterilization method incorrect
Root cause tag: sterility
FDA 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 in commerce: 2 boxes
Distribution: The product was shipped to a wholesaler in Japan.
Product codes and lots: Model number DB513, Lot number M384030 exp. 7/08

Product code GAT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)