FDA
Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001
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.
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.