Recall Z-0936-04 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
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)
| Date | Jul 20, 2004 (initiated Aug 25, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.