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Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

FDA product code MAY · Class 2 · Orthopedic

4,122
Registered devices
499
Adverse events
19
Recalls
4
510(k) clearances

Devices with this code

P.C.A. — Howmedica Osteonics Corp.Arcos® STS™ Modular Revision System — Biomet Orthopedics, LLCINSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.Arcos Modular Revision Hip System — Biomet Orthopedics, LLCRestoration — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.P.C.A. — Howmedica Osteonics Corp.Arcos® STS™ Modular Revision System — Biomet Orthopedics, LLCOrthinox — Howmedica Osteonics Corp.Restoration — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.Echo® Press-Fit Hip System — Biomet Orthopedics, LLCRingLoc Hip System — Biomet Orthopedics, LLCINSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.Arcos® STS™ Modular Revision System — Biomet Orthopedics, LLCINSTRUMENT — Howmedica Osteonics Corp.Profemur — Microport Orthopedics Inc.Arcos Modular Revision Hip System — Biomet Orthopedics, LLC

Recent recalls

DateFirmReason
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
2016-01-21Stryker Howmedica Osteonics Corp.During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.