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Recall Observatory FDA recall evidence

Device product

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

Z-2212-2014

June 23, 2014

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 68651
Status
Terminated
Classification
Class II
Quantity
37
Official record key
device-enforcement:Z-2212-2014

Official wording

Reason: 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.

Code information: Catalog Number: DNPDG, Lot Number: NB0311 and NB0611

Distribution pattern: The product was distributed domestically and to internationally. Domestically to CA, PA, IA, CO, NY, MD, NC,AL, AZ, IL, GA, VA. Netherlands, Argentina,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.