Synvasive Technology

4 recalls •

🏥 Medical Devices

• Categories: Infusion Pumps, Surgical Instruments, Implants & Prosthetics

ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer

Class I - Dangerous

Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.

Jul 27, 2018 Infusion Pumps View Details →

Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures

Class I - Dangerous

Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.

Dec 8, 2015 Surgical Instruments View Details →

The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.

Class I - Dangerous

Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.

Mar 14, 2013 Implants & Prosthetics Nationwide View Details →

Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.

Class I - Dangerous

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.

Apr 2, 2013 Implants & Prosthetics Nationwide View Details →