Home › Device types › MRA
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA product code MRA · Class 3 · Unknown
846
Registered devices
5,353
Adverse events
23
Recalls
0
510(k) clearances
Devices with this code
REFLECTION — Smith & Nephew, Inc.Profemur — Microport Orthopedics Inc.S-ROM — DEPUY ORTHOPAEDICS, INC.Profemur — Microport Orthopedics Inc.Perfecta — Microport Orthopedics Inc.S-ROM ZTT — DEPUY (IRELAND)PINNACLE POROCOAT — DEPUY ORTHOPAEDICS, INC.PINNACLE POROCOAT — DEPUY ORTHOPAEDICS, INC.S-ROM — DEPUY ORTHOPAEDICS, INC.ANTHOLOGY — Smith & Nephew, Inc.TRI-LOCK GRIPTION — DEPUY ORTHOPAEDICS, INC.Perfecta — Microport Orthopedics Inc.Profemur — Microport Orthopedics Inc.TRI-LOCK GRIPTION — DEPUY ORTHOPAEDICS, INC.Lineage — Microport Orthopedics Inc.Profemur — Microport Orthopedics Inc.S-ROM — DEPUY ORTHOPAEDICS, INC.Lineage — Microport Orthopedics Inc.SPECTRON — Smith & Nephew, Inc.DJO SURGICAL — Encore Medical, L.P.CERAMAX — DEPUY (IRELAND)Novation Ceramic AHS — Exactech, Inc.S-ROM — DEPUY (IRELAND)S-ROM — DEPUY ORTHOPAEDICS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-04-12 | Exactech, Inc. | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| 2016-04-12 | Exactech, Inc. | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| 2016-04-12 | Exactech, Inc. | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| 2016-04-12 | Exactech, Inc. | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| 2016-04-12 | Exactech, Inc. | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| 2016-04-12 | Exactech, Inc. | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. |
| 2013-10-11 | Zimmer, Inc. | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this r |
| 2012-09-14 | Zimmer, Inc. | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specifica |
| 2012-09-14 | Zimmer, Inc. | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specifica |
| 2011-03-11 | Smith & Nephew Inc | During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than a |
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