Class II — MicroPort Orthopedics Inc.
| Recalling firm | MicroPort Orthopedics Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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). |
| 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 COBA… |
| 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. |
| Initiated | 2020-07-31 |
| Classified | 2020-09-09 |
| Recall number | Z-2948-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MicroPort Orthopedics Inc. (Z-2948-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86211/
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