Recall Z-1538-2018 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet, Inc.
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
| Date | Apr 2, 2018 |
| Status | Terminated |
| Reason | Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 4/2/2018 to its customers. The letter described the product, problem and actions to be taken. Distributors will be notified of the recall via email. Hospital risk managers and distributors with product will be notified via courier. The distributor letter includes instructions to locate and remove the product in their territory, identify hospitals who have previously used the product; return on-hand product to the recalling firm and ensure all products are accounted for. The letter for hospital risk managers instruct t |
| Quantity | 18 |
| Distribution | Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032396 | RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS Biomet, Inc., Aug 21, 2003 |