Recall Z-1308-06 ยท JDR Staple, Fixation, Bone
Boston Scientific Corp
Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000).
| Date | Aug 2, 2006 (initiated Jun 2, 2006) |
| Status | Terminated |
| Reason | The packages are labeled sterile, but the product was not sterilized. |
| Root cause | Other |
| Action | Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products. |
| Quantity | 22 kits. |
| Distribution | Nationwide, including California, Florida, Kansas, North Carolina, Oklahoma, South Dakota, Tennessee, West Virginia and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932925 | BONE ANCHOR FOR SOFT TISSUE ATTACHMENT Vesitec Medical, Inc., Apr 26, 1994 |