Home › Device types › HWE
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
FDA product code HWE · Class 1 · General, Plastic Surgery
9,021
Registered devices
50,638
Adverse events
101
Recalls
76
510(k) clearances
Devices with this code
CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.NA — NOVASTEPEMERGE MEDICAL & Design — EMERGE MEDICAL, INC.NA — Conmed CorporationCD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.NA — Smith & Nephew, Inc.DYONICS — Smith & Nephew, Inc.ACETABULAR REAMER D48 mm HPF — HPF SRLNA — Synthes GmbHACETABULAR REAMER EVO 2 D54 mm — HPF SRLPOWEREASE™ Instruments — MEDTRONIC SOFAMOR DANEK, INC.CD HORIZON® SOLERA® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.MECTRON — MECTRON SPAACETABULAR REAMER D71 mm FC — HPF SRLPS3500 — Smith & Nephew, Inc.ACETABULAR REAMER D63 mm FC — HPF SRLMill Plus — STRYKER CORPORATIONCD HORIZON® SOLERA® VOYAGER™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.CD HORIZON® SOLERA® VOYAGER™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.NA — STRYKER CORPORATIONEZX Blade — IMEDICOM CO., LTD.R3 — Smith & Nephew, Inc.Arthrex® — ARTHREX, INC.ITST® — Zimmer, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-09-19 | Encore Medical, Lp | Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could re |
| 2017-09-29 | The Anspach Effort, Inc. | This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account. |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the su |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the su |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the su |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the su |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the su |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the su |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the su |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the su |
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