Home › Device types › HAB
Saw, Powered, And Accessories
FDA product code HAB · Class 1 · General, Plastic Surgery
568
Registered devices
9,999
Adverse events
16
Recalls
2
510(k) clearances
Devices with this code
NA — Smith & Nephew, Inc.MEDLINE — MEDLINE INDUSTRIES, INC.NA — Smith & Nephew, Inc.NA — Smith & Nephew, Inc.Zimmer Biomet™ — Zimmer Surgical SAFJ2000 System — Paragon 28, Inc.Zimmer Biomet™ — Zimmer Surgical SAZimmer Biomet™ — Zimmer Surgical SASaw blade 6.3/6/0.4mm — Nouvag AGNA — Smith & Nephew, Inc.DYONICS POWER — Smith & Nephew, Inc.NA — Smith & Nephew, Inc.DYONICS POWER — Smith & Nephew, Inc.NA — Smith & Nephew, Inc.DYONICS POWER — Smith & Nephew, Inc.DYONICS, ACROMIONIZER — Smith & Nephew, Inc.NA — Smith & Nephew, Inc.FJ2000 System — Paragon 28, Inc.NA — Smith & Nephew, Inc.PLATINUM — Smith & Nephew, Inc.NA — Smith & Nephew, Inc.Baby Gorilla/Gorilla Plating System — Paragon 28, Inc.HALL MICROPOWER+ — Conmed CorporationN/A — Smith & Nephew, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-27 | Arthrex, Inc. | The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2017-02-02 | Smith & Nephew, Inc. | The single use devices are provided sterile and do not have an expiration date on the label. |
| 2016-09-28 | Zimmer Biomet, Inc. | Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance |
| 2015-11-10 | Zimmer, Inc. | The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. |
| 2015-11-10 | Zimmer, Inc. | The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. |
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