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.
FDA Recall Z-2116-2009 · Posted 2009-09-21
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Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeHSB
Date Initiated2009-03-27
Date Terminated2009-09-23
Product Quantity5
Reason for Recall
Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- USA and Spain.
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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