Recall Z-0824-2015 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Manufacturing B.V.
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 individ
| Date | Dec 17, 2014 (initiated Nov 21, 2014) |
| Status | Terminated |
| Reason | 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. . |
| Root cause | Equipment maintenance |
| Action | 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 routin |
| Quantity | 6,377 |
| Distribution | 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 Norwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934765 | TRILOGY ACETABULAR SYSTEM Zimmer, Inc., Apr 29, 1994 |