Z-2116-2009

Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100...

Name: Z-2116-2009 Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100...
Creator: Ebi, L.p.
Published: 2009-03-27
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2009-03-27 / Terminated / root cause: manufacturing process

FDA source

EBI, L.P. began a recall of Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 Intended to aid... on 2009-03-27. The reason FDA records is "Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2116-2009
Status: Terminated
Initiated: 2009-03-27
Posted: 2009-09-21
Terminated: 2009-09-23
Recalling firm: Ebi, LLC
Product: Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.
Quantity in commerce: 5
Distribution: Worldwide Distribution -- USA and Spain.
Product codes and lots: Catalog number: 33-345532; Lot number 598990

Product code HSB

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)