Reported Dec 30, 2015 · Terminated

Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot…

Synvasive Technology Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synvasive Technology Inc · 4925 Robert J Mathews Pkwy · El Dorado Hills, CA · 95762-5701

Is this the product you have?

  • 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 DescriptionSTRYK_76542K_19X75X1.27T
  • General and Plastic SurgeryThe oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
Lot codes and dates
  • Synvasive Part number11-4770
  • Part number19075127YT1
  • Lot numbers45104 and 43054
Amount recalled
14

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 1, 2016 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.