Reported Aug 21, 2013 · Terminated
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior…
OrthoPediatrics Corp.
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: OrthoPediatrics Corp · 2850 Frontier Dr · Warsaw, IN · 46582-7001
Is this the product you have?
- 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
- Lot codes and dates
- LOT 91300335 - Catalogue Number 01-1050-0002
- Amount recalled
- 68
Where it was sold
Why it was recalled
OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
This product could cause temporary or reversible health problems — stop using it.
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