Blade, Saw, General & Plastic Surgery, Surgical
General, Plastic Surgery · 21 CFR 878.4820
Recent MDR events
5,861 adverse event reports on file
- POWERPICK, 45 DEGJul 29, 2026MalfunctionArthrex, Inc.1220246-2026-04100
- HALL PRIMECUTJul 28, 2026InjuryConmed1017294-2026-00144
- SABRE, SJ 3.0MM 7CMJul 28, 2026MalfunctionArthrex, Inc.1220246-2026-04068
- TORPEDO, 4.0MM X 13CMJul 27, 2026MalfunctionArthrex, Inc.1220246-2026-04023
- OSCILLATING SAW ATTACHMENT IIJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07638
- RESECTOR SHAVER BLADE F-SERIES 4.0MM EACH - ORDER MULTIPLES OF 5Jul 27, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00517
- RECIPROCATING BLADE HEAVY DUTY LONG, OFFSET (77.6 X 0.77 X 11.2MM)Jul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99345
- DUAL CUT SAGITTAL BLADE (25 X 90 X 1.27MM)Jul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99331
- MICRO SAGITTAL BLADE OFFSET (19.0 X 0.51 X 41.0MM)Jul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99335
- PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.19X100)Jul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99343
Event type breakdown
Recalls
19 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedJan 11, 2023
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number.
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
Z-0930-2023 · View FDA record ↗ - Surgical Instrument Service And Savings, Inc.TerminatedJul 1, 2013
- Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Z-1630-2013 · View FDA record ↗ - Synvasive Technology IncTerminatedApr 15, 2013
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hi
Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
Z-1115-2013 · View FDA record ↗ - Stryker EndoscopyTerminatedJun 25, 2012
Formula Shaver Handpiece (with buttons);
Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.
Z-1866-2012 · View FDA record ↗ - Linvatec Corp. dba ConMed LinvatecTerminatedFeb 10, 2012
***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LAR
ConMed Linvatec, Largo, FL recalled catalog number, C9944A, lot # 95987, 2.9MM Full Radius Resector Blade in November 2009 because there was a possibility that the device was assembled with an incorrect outer tube.
Z-0987-2012 · View FDA record ↗ - Stryker Instruments Division of Stryker CorporationTerminatedJul 12, 2011
Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Sing
Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle.
Z-2794-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorporationTerminatedJan 26, 2011
Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI.
The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide sterlized but the product actually was sterilzed with gamma radiation.
Z-0968-2011 · View FDA record ↗ - Linvatec Corp. dba ConMed LinvatecTerminatedSep 25, 2010
GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.
ConMed Linvatec, Largo, FL is recalling ConMed Linvatec 9263A,4.2mm Sterling Blade, Gator Meniscus Cutter, Lot Number 178026 for breech in the sterile barrier.
Z-2503-2010 · View FDA record ↗ - Sterilmed IncTerminatedJan 13, 2009
Saw Blade
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
Z-0569-2009 · View FDA record ↗ - Terumo Cardiovascular Systems CorporationTerminatedDec 2, 2008
Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670.
The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.
Z-0358-2009 · View FDA record ↗
Registered firms
319 firms currently registered for this product code
W&h Dentalwerk Buermoos Gmbh - Site 2
BUERMOOS Salzburg, AT
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Depuy Orthopaedics
BRIDGEWATER, MA, US
Green Or Llc
Lakeville, MN, US
Kirwan Surgical Products, Llc.
MARSHFIELD, MA, US
Bauer Und Haselbarth-chirurg Gmbh
ELLERAU Schleswig-Holstein, DE
Lighthouse Tech
Chandler, AZ, US
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Cadence Inc.
Staunton, VA, US
Takumi Precision Engineering Ltd
Limerick, IE
Jabil Switzerland Manufacturing Gmbh (bettlach)
Bettlach Solothurn, CH
Surgix Medical Llc
Spring, TX, US
Shenzhen Yiguangnian Innovation Technology Co., Ltd.
Shenzhen Guangdong, CN
Putnam Precision Products, Inc.
BREWSTER, NY, US
Synthes (usa) Products Llc
West Chester, PA, US
Stryker Gmbh
SELZACH Solothurn, CH
Stryker Puerto Rico, Llc.
ARROYO, PR, US
Phoenix Instruments, Inc.
Lisle, IL, US
Sinntech Medical (private) Limited
Sialkot Punjab, PK
Chlorophyllic Concepts (opc) Private Limited
Thane Maharashtra, IN
S.r.r. Surgical Co
Sialkot Punjab, PK
Hipp Medical Ag
Renquishausen Baden-Wurttemberg, DE
Jabil Inc. (elmira)
Horseheads, NY, US
Nsk America Corp.
Hoffman Est, IL, US
Nuell, Inc.
LEESBURG, IN, US
510(k) clearances
27 clearances for this product code
- WrightmedicaltechnologyincJun 18, 1997
K971978 · GRAFT HARVESTING SAWBLADES
- Stryker InstrumentsJan 30, 1996
K954483 · STRYKER SAGITTAL SAW ATTACHMENT
- WrightmedicaltechnologyincJan 18, 1996
K955229 · WRIGHT MEDICAL TECHNOLOGY SAWBLADES
- Boston Surgical Products, Inc.Jul 12, 1995
K953012 · DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
- Transidyne General Corp.Feb 21, 1995
K950403 · SURGICAL SAW BLADES
- Adven MedicalJun 28, 1994
K940501 · RE-SHARPENABLE SAW BLADES
- Omega Surgical Instruments, Inc.Mar 16, 1994
K933595 · BUR, SURGICAL, GENERAL & PLASTIC SURGERY
- 3M Health Care, SarnsFeb 24, 1994
K935391 · SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK