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
Check against the official notice below — it lists the full affected range.
MicroPort Orthopedics Inc. is voluntarily recalling 12,348 units of PROFEMUR Titanium and Cobalt Chrome modular necks that were distributed worldwide, including throughout the United States and in Brazil, Canada, China, Costa Rica, France, Germany, Japan, The Netherlands, and the United Kingdom. The recall affects products with previous package insert versions and involves numerous lot codes spanning multiple product batches.
The reason for the recall is to replace the PROFEMUR Hip System Package Insert with the most recent revision (150803-8). The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). 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. Quantity: 12,348 units Lot/code info: All lots 1431860 1435705 1430154 1431065 1431308 1436522 1437003 0298131491437686 06113732261437685 1286531651437687 1430775 1431243 1431309 1431622 1431825 1431864 1432439 1432440 1433425 1433430 1433432 1433433 1434152 1435449 1435602 1435699 1435700 1436524 1436526 1436556 1437004 W123831741436428 1433424 1434969 14080361437684 1433431 1434993 1436525 1436527 1436528 1438068 1438130 1435702 1437055 1438069 1438131 1438455 X013918551437840 14277201440118 1434151 1434965 1435450 1435701 1435727 1435728 1436529 1436557 1436713 1438245 1438609 1438456 1438775 1438776 0398262151439704 1435603 1436712 1438872 1439145 V072510101439739 W0989675B1439738 1437581 1437877 1438664 1438873 1439144 1439379 1439380 1439387 1439582 U06811981440149 U06811981440151 V062154321440171 V092442911440169 1432436 1434964 1436365 1439944 1439945 1439946 W063349591440289 W073506871440084 1437451 1437582 1438953 1439581 1439947 U11852411440150 V062154311440165 V072329521440166 W093590691440288 W09919661440428 W103727321440287 1435852 1436366 1440186 1436367 1433438 1434153 1436555 1437050 1437580 1440654 1436364 1436711 1440187 1438954 1440655 1437057 1437876 1438297 1438454 1439325 1439512 1439513 1440239 1439323 1439750 1439752 1440238 1440575 1440576 1441171 1439514 1441170 1441535 1439753 1442404 01010095631444294 01112878341444296 0197579261444305 0197610691444306 0197842261444320 0285403251444307 0285523101444308 0285562241444309 02895142011444310 0297967521444312 0485730671444289 06113570991444
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.