Extractor
FDA product code HWB · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
5510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873710 | Magnetic Retriever, 1.7MM W/Luer Fitting TM-1350HWB · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K870844 | Schultz Prosthesis Component Inserter ExtractorHWB · Traditional | Warsaw Orthopedic, Inc. | 03/13/1987SE |
| K870083 | Ferray ExtractorHWB · Traditional | Terray Manufacturing, Inc. | 02/26/1987SE |
| K801327 | The Extractor I TMHWB · Traditional | The Anspach Effort, Inc. | 06/09/1980SE |
| K780300 | Hip Plate Removal InstrumentHWB · Traditional | Richard'S Medical Equip., Inc. | 02/28/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1753-2024 Class II | INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter… | Innomed, Inc. | 03/07/2024Completed |
| Z-1514-2018 Class II | Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and…There is a potential for the connection screw of the stem extractor to break. | Synthes, Inc. | 03/19/2018Terminated |
| Z-0828-2011 | CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore…Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay. | Encore Medical, Lp | 11/10/2010Terminated |
| Z-1443-2010 | Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists…Literature did not include the design change to a smaller cannulation diameter. | Stryker Howmedica Osteonics Corp. | 03/02/2010Terminated |