FDA-Device2022-10-26Class II
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Synthes (USA) Products LLC
Hazard
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Sold states
US Nationwide distribution.
Affected count
196
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0101-2023Don't want to check this manually?
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