RecallRadar

FDA Device recall Z-0466-2016

Zimmer Oscillating Flat - TS ST Hub

On 2015-12-30 the FDA classified a Class II recall of Zimmer Oscillating Flat - TS ST Hub by Synvasive Technology, citing two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0466-2016
ClassificationClass II
Statusterminated
Initiated2015-12-08
Published2015-12-30
Last updated2026-09-13 11:53 UTC
CompanySynvasive Technology
DistributionCA, CT, MA

Product

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

Reason

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

Identifiers

code_infoSynvasive Part number: 11-4770; Part number: 19075127YT1; Lot numbers: 45104 and 43054.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0466-2016%22

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