Home › Device types › GFA
Blade, Saw, General & Plastic Surgery, Surgical
FDA product code GFA · Class 1 · General, Plastic Surgery
11,578
Registered devices
5,861
Adverse events
19
Recalls
27
510(k) clearances
Devices with this code
MicroAire — ProvisionReprocessed Dual Cut Sagittal Blade, 25 x 90 x 1.27 mm — SURETEK MEDICALConMed Linvatec — ProvisionMedline — MEDLINE INDUSTRIES, INC.Medline — MEDLINE INDUSTRIES, INC.KOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KGBrasseler USA — Peter Brasseler Holdings, LLCMEDLINE — MEDLINE INDUSTRIES, INC.Medline — MEDLINE INDUSTRIES, INC.Reprocessed Heavy Duty Sagittal Blade, Straight Offset — SURETEK MEDICALKOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KGN/A — Omega Surgical Instruments IncN/A — Omega Surgical Instruments IncStryker — ProvisionKM Saw Blade — Gebr. Brasseler GmbH & Co. KGBodyMed — BOXOUT, LLCIMEDICOM SAW BLADE — IMEDICOM CO., LTD.EXPLOR PROVISIONAL LOCKING SCREW — Biomet Orthopedics, LLCKOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KGReplacement Precision Micro Saw Blade — Gebr. Brasseler GmbH & Co. KGMedline — MEDLINE INDUSTRIES, INC.DYONICS — Smith & Nephew, Inc.NA — STERILMED, INC.MICROCHOICE — Conmed Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. |
| 2019-03-19 | Stryker Instruments Div. of Stryker Corporation | During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility. |
| 2018-07-27 | Synvasive Technology Inc | Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. |
| 2015-12-08 | Synvasive Technology Inc | Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm. |
| 2015-10-14 | Stryker Sustainability Solutions | It was reported that packaging was not properly sealed. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2013-04-02 | Synvasive Technology Inc | Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actuall |
| 2012-05-21 | Stryker Endoscopy | Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific s |
| 2011-06-13 | Stryker Instruments Division of Stryker Corporation | Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle. |
| 2010-10-20 | Terumo Cardiovascular Systems Corporation | The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product |
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