Z-2212-2014 Class II Terminated
FDA device recall Z-2212-2014 was initiated by Biomet, Inc. on Jun 23, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Jul 14, 2015). Affected quantity: 37.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 20, 2014
- Initiation Date
- Jun 23, 2014
- Termination Date
- Jul 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37
Product Description
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
Reason for Recall
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.
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,
Code Information
Catalog Number: DNPDG, Lot Number: NB0311 and NB0611
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2212-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026