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OSS PROXIMAL FEMORAL INSERTER

Biomet Orthopedics, LLC · Model 110024553 · UDI-DI 00880304683075

HWR Prescription

510(k) clearances

9,682

Adverse events (1 deaths)

Recalls

176

Facilities

Recalls

Date	Firm	Reason
2016-01-05	Biomet U.K., Ltd.	Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to pro
2016-01-05	Biomet U.K., Ltd.	Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to pro
2013-04-04	Smith & Nephew, Inc., Endoscopy Div.	Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
2010-01-15	Biomet Microfixation, Inc.	The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone cons
2007-10-10	Pioneer Surgical Technology	The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
2007-10-04	Wright Medical Technology Inc	Breakage: breaking of the connecting foot that is on the distal surface of the instrument

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.