Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010
FDA Recall Z-1501-06 · Posted 2006-09-13
Recalling FirmXiros Plc
Recall StatusTerminated
Product CodeHXJ
Date Initiated2006-05-17
Date Terminated2012-09-14
Product Quantity10, none distributed in US
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide & Worldwide, including Spain, Japan, UAE, Italy, Germany
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.