FDA-Device2013-12-04Class II
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Synthes USA HQ, Inc.
Hazard
During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
Sold states
Nationwide Distribution
Affected count
3087
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0394-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief