Recall Z-2948-2020 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
MicroPort Orthopedics Inc.
PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224
| Date | Sep 9, 2020 (initiated Jul 31, 2020) |
| Status | Open, Classified |
| Reason | MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR Hip System Package Insert with the most recent revision (150803-8). |
| Root cause | Labeling Change Control |
| Action | The firm, MicroPort Orthopedics Inc., disseminated a "URGENT ACTION REQUIRED" VOLUNTARY DEVICE PRODUCT RECALL notice dated 7/31/2020 by mail to its consignees. The letter directed the consignee to doe the following: Please check your stock, including all consignment stock to immediately determine if you have any affected product. PLEASE NOTE: No other MicroPort Orthopedics Inc. products are involved in this recall. If product(s) is(are) located, please return immediately to the MicroPort Orthopedics Inc. Distribution Center at: 11481 Gulf Stream, Arlington, TN 38002. Mark all return ship |
| Quantity | 12,348 units |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT, NC, NH, NJ, NV, OH, PA, TN, TX, UT, VA, WA, WI including PR; and countries of: Brazil, Canada, China, Costa Rica, France, Germany, Japan, The Netherlands and United Kingdom. |
| FDA record | Open on fda.gov |