Recall Z-1501-06 ยท HXJ Staple Driver
Xiros Plc
Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010
| Date | Sep 13, 2006 (initiated May 17, 2006) |
| Status | Terminated |
| Reason | The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles. |
| Root cause | Other |
| Action | Customer recall notifications included: a) Telephone notification to highest volume users b) Recall letters were sent via certified mail to all customers June 1, 2006. Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible. |
| Quantity | 10, none distributed in US |
| Distribution | Nationwide & Worldwide, including Spain, Japan, UAE, Italy, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.