Reported Jun 16, 2021 · Terminated
WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US,…
Wishbone Medical, 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: Wishbone Medical, Inc. · 100 Capital Dr · Warsaw, IN · 46582-6704
Is this the product you have?
- WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut
- Part Number
PK-SMC0635NL-TI-USPK-SMC0635NR-TI-USPK-SMC0835NSL-TI-USPK-SMC0835NSR-TI-US
- Lot codes and dates
- Lot Number
85 of 85 codes
2083712455512455712455812455712455612455512455412455312455212455112455012454812454712454612454512463612463412463212463112463022571208462084520844208422409222461242872409124282224622246324090242892083722464242842246522014242852255422466221962429222529240852219522469242912255324083240872247024283225602408224088124630134631
- Lot Number
- Amount recalled
- 60 products
Where it was sold
Why it was recalled
Nonconformities were discovered to the engineering specifications for implant plates and screws.
This product could cause temporary or reversible health problems — stop using it.
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