Reported Dec 24, 2014 · Terminated
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The…
Zimmer Manufacturing B.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Manufacturing B.V. · N/A · N/A · N/A
Is this the product you have?
- Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
- Lot codes and dates
- Item Number Lot Number2
00-6250-065-356274808900-6250-065-356275432900-6250-065-356279349400-6250-065-356279349500-6250-065-356279350100-6250-065-356279350200-6250-065-356279350300-6250-065-356281361200-6250-065-356281361300-6250-065-256278461700-6250-065-2562784618
00-6250-065-256278461900-6250-065-256278462100-6250-065-256278462200-6250-065-256281870100-6250-065-256281870200-6250-065-256281870300-6250-065-256281870700-6250-065-256281870900-6250-065-256281871000-6250-065-256282561100-6250-065-2562836984
- Item Number Lot Number
- Amount recalled
- 6,377
Where it was sold
- Nationwide
Why it was recalled
Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .
This product could cause temporary or reversible health problems — stop using it.
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