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Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
FDA product code HSZ · Class 1 · General, Plastic Surgery
638
Registered devices
1,088
Adverse events
6
Recalls
56
510(k) clearances
Devices with this code
NA — Synthes GmbHNA — Synthes GmbHMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSNA — Synthes GmbHNA — Anspach Effort, TheMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSCORB® — Zimmer, Inc.Midas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSNA — Synthes GmbHMIDAS REX MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSNA — Synthes GmbHNA — Anspach Effort, TheMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMIDAS REX MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMicroAire® — Microaire Surgical Instruments LLCMidas Rex — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSMidas Rex MR8 — MEDTRONIC POWERED SURGICAL SOLUTIONSNA — Exactech, Inc.NA — Synthes GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-24 | Synthes (USA) Products LLC | Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 | Synthes (USA) Products LLC | Products not sterilized, sterility cannot be confirmed |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2014-05-08 | The Anspach Effort, Inc. | Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Di |
| 2013-04-25 | The Anspach Effort, Inc. | The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot co |
| 2011-05-06 | The Anspach Effort, Inc. | Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart |
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