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.
Recall
- Recall Number
- Z-0824-2015
- Event Number
- 69851
- Firm
- Zimmer Manufacturing B.V.
- FEI Number
- 1000132037
- Product Code
- LPH
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- November 21, 2014
- Posted
- December 17, 2014
- Terminated
- August 10, 2015
Description
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.
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. .
Zimmer sent an Urgent Medical Device Recall letter dated November 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of the contents. Customers were advised to quarantine any affected product and notify their Zimmer sales representative who will remove the recalled product from their facility. For patients who previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
Worldwide Distribution - USA (nationwide) and Internationally to Canada Australia Brazil Chile China Colombia Japan Malaysia Singapore South Korea Taiwan Albania Austria Belgium Bulgaria Canary Islands Czech Republic Denmark Egypt Finland France Germany Greece Hungary Ireland Italy Netherlands Norway Poland Portugal Russia Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey and United Kingdom.
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