Recall Z-0875-2015 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Manufacturing B.V.
Trilogy Fiber Metal Acetabular Shell Size 54 mm OD 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
| Date | Dec 24, 2014 (initiated Dec 4, 2014) |
| Status | Terminated |
| Reason | Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which |
| Root cause | Under Investigation by firm |
| Action | The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" memo dated 12/4/2014 to its customers. The memo described the product, problem and actions to be taken. The customers were instructed to locate all product from the listed lot and quarantine them immediately; carry out a physical count of all affected product in inventory; complete and return the Inventory Return Certification Form via email to: corporatequality.postmarket@zimmer.com on or before 12/12/2014; return the recalled product along with Inventory Return Certification Form on or before 12/12/2014; keep and maintain |
| Quantity | 68 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934765 | TRILOGY ACETABULAR SYSTEM Zimmer, Inc., Apr 29, 1994 |