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

Recall date

December 8, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0466-2016

FDA classification

Class II

Brand / firm

Synvasive Technology Inc

Sold / distributed

US Distribution to one location each in CT, MA and CA.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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