Home › Device types › LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
FDA product code LWJ · Class 2 · Orthopedic
0
Registered devices
4,174
Adverse events
26
Recalls
81
510(k) clearances
Devices with this code
Echo® Press-Fit Hip System — Biomet Orthopedics, LLCUSTAR II Knee System — UNITED ORTHOPEDIC CORP.Trident — Howmedica Osteonics Corp.Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KGINSTRUMENT — Howmedica Osteonics Corp.Avenir® Müller — Zimmer GmbHTrident — Howmedica Osteonics Corp.SL-PLUS — Smith & Nephew, Inc.ZMR® — Zimmer, Inc.INSTRUMENT — Howmedica Osteonics Corp."UNITED" USTAR II Knee System — UNITED ORTHOPEDIC CORP.NA — Zimmer, Inc.INSTRUMENT — Howmedica Osteonics Corp.Morse Head — Howmedica Osteonics Corp.U2 Hip Stem — UNITED ORTHOPEDIC CORP."UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP.Trinity Acetabular Hip System — CORIN LTDINSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.N/A — Exactech, Inc.United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP.Centralizer — Howmedica Osteonics Corp.SUMMIT — DEPUY ORTHOPAEDICS, INC.Iconacy i-Hip — Iconacy Orthopedic Implants LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-01 | Howmedica Osteonics Corp. | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac |
| 2023-12-01 | Howmedica Osteonics Corp. | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac |
| 2020-07-31 | MicroPort Orthopedics Inc. | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantatio |
| 2020-07-31 | MicroPort Orthopedics Inc. | MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert ver |
| 2020-07-31 | MicroPort Orthopedics Inc. | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantatio |
| 2016-06-30 | MicroPort Orthopedics Inc. | Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck). |
| 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 |
| 2009-06-18 | Stryker Howmedica Osteonics Corp. | Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not |
| 2009-05-15 | Zimmer Inc. | The threads on the screw are incomplete/non-functional. |
| 2008-10-31 | Stelkast Co | A possible breach of the sterile barrier packaging (Tyvek pouch). |
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