Home › Device types › GFA
Blade, Saw, General & Plastic Surgery, Surgical
FDA product code GFA · Class 1 · General, Plastic Surgery
11,599
Registered devices
5,904
Adverse events
19
Recalls
27
510(k) clearances
Devices with this code
NA — STERILMED, INC.Brasseler USA — Peter Brasseler Holdings, LLCHNM MEDICAL — HNM STAINLESS, LLC.MINI-DRIVER — Conmed CorporationReprocessed Sagittal Blade, 18mm x 90mm x 1.27mm — SURETEK MEDICALBrasseler USA — Peter Brasseler Holdings, LLCMicroAire — ProvisionStablecut® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.Stablecut® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.Stablecut® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.KOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KGCONMED — Conmed CorporationN/A — Omega Surgical Instruments IncIMEDICOM SAW BLADE — IMEDICOM CO., LTD.NA — STERILMED, INC.KOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KGCompetitive Micro Premium Blade for ConMed®/Linvatec® Hall® — Gebr. Brasseler GmbH & Co. KGKOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KGSustainable Technologies — ProvisionKOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KGNA — Synthes GmbHCompetitive Micro Saw Blade for ConMed®/Linvatec® Hall® — Gebr. Brasseler GmbH & Co. KGStablecut® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.Stablecut® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.