FDA-Device2014-08-20Class II
Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
Biomet, Inc.
Hazard
The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.
Sold states
The product was distributed domestically and to internationally. Domestically to CA, PA, IA, CO, NY, MD, NC,AL, AZ, IL, GA, VA. Netherlands, Argentina,
Affected count
37
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2212-2014Don't want to check this manually?
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