PROFEMUR Titanium and Cobalt Chrome modular necks — Class II medical device recall Z-2948-2020
Ongoing recall by MicroPort Orthopedics Inc., reported 2020-09-16, distributed nationwide. MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Ch
| Recall number | Z-2948-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MicroPort Orthopedics Inc., Arlington, TN, United States |
| Recall initiated | 2020-07-31 |
| Classified | 2020-09-09 |
| Reported by FDA | 2020-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CN, CR, DE, FR, GB, JP, NL |
| Quantity | 12,348 units |
| UPC / GTIN / UDI-DI | 03667181482642, 06665751467959, 07764931449798, 09896821451043, 10147421739786, 10163101740255, 11005511749246, 11145131754173, 11211071747336, 11471291753528, 11589121775791, 11725471625281, 13795111530747, 13942391607816, 13986211805662, 14003301689168, 14016251778752, 14025031689102, 14071071473317, 14125261570079, 14128301636315, 14138061602567, 14141441761570, 14186751658790, 14186751721272 and 220 more |
| Lot numbers | 01010017461463457, 01010023091459188, 01010095631444294, 01010135791469569, 01010147751449539, 01010147771468867, 01010179871454266, 01010185531467440, 01010185531467839, 01010186041468869, 01010209461463393, 01010209461463408, 01010209681452418, 01010209731468870, 01010231841463429, 01010231951467441, 01010231951467840, 01010245651460383, 01010245691467442, 01010245691467841, 01010262141467443, 01010262141467842, 01010271781463458, 01010271781496271, 01010284621463459, 01010284621496272, 01010304091454267, 01010304131468871, 01010306751463440, 01010306761463441, 01010306761470480, 01010348151452419, 01010348171468872, 01010355941463447, 01010355971496274, 01010356111470463, 01010356111496250, 01010356271451695, 01010356271452380, 01010368331454254 and 460 more |
Product
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 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG A/R LONG PHA01252 PROFEMUR NECK 8DG VAR/VAL SHORT PHA01254 PROFEMUR NECK 8DG VAR/VAL LONG PHA01256 PROFEMUR NECK 8DG VAR/VAL X LONG PHA01262 PROFEMUR NECK 15DG VAR/VAL SHORT PHA01264 PROFEMUR NECK 15DG VAR/VAL LONG Intended Use: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2948-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.