Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.
FDA Recall Z-0918-05 · Posted 2005-06-22
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Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeHXI
Date Initiated2005-03-16
Date Terminated2006-06-30
Product Quantity152 units
Reason for Recall
The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.
Firm Action
The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005.
Root Cause
Other
Distribution Pattern
These devices are distributed nationwide to sales representatives who provide the product directly to the hospital/physician at the time of the surgery. The product was also distributed to Italy and Spain. There are no government accounts.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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