Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010

FDA device recall Z-1501-06 · posted 2006-09-13 · Terminated

Recall details

Recalling firm

Xiros Plc

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.

Action taken

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

Status

Terminated

Product code

HXJ

Quantity affected

10, none distributed in US

Distribution

Nationwide & Worldwide, including Spain, Japan, UAE, Italy, Germany

Date initiated

2006-05-17

Date posted

2006-09-13

Date terminated

2012-09-14

Location

Leeds, United Kingdom