Z-0918-05

Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640

Name: Z-0918-05 Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640
Creator: Ebi, L.p.
Published: 2005-03-16
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2005-03-16 / Terminated

FDA source

EBI, L.P. began a recall of Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640 on 2005-03-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0918-05
Status: Terminated
Initiated: 2005-03-16
Posted: 2005-06-22
Terminated: 2006-06-30
Recalling firm: Ebi, LLC
Product: Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.
Product code: HXI Passer, Wire, Orthopedic
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.
FDA root cause: Other
Action: The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005.
Quantity in commerce: 152 units
Distribution: 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.
Product codes and lots: Lot Numbers: 065882; 122235; 132557; 132560; 877265.

Product code HXI

K982953Class IITitanium Intramedullary Nails-Various StylesBiomet, Inc. / cleared 1998-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)