Z-2212-2014Class II

Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone...

Name: Z-2212-2014 Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone...
Creator: Biomet, Inc.
Published: 2014-06-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-06-23 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling... on 2014-06-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2212-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-23
Posted: 2014-08-13
Terminated: 2015-07-14
Recalling firm: Zimmer GmbH
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
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On June 23, 2014 Biomet issued recall notification to their consignees via letter. Notification included affected product issue and instructions for return were provided. Distributors who had affected hospitals in their regions were notified and provided with a copy of the notice that was sent to the hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. A response form was provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis.
Quantity in commerce: 37
Distribution: The product was distributed domestically and to internationally. Domestically to CA, PA, IA, CO, NY, MD, NC,AL, AZ, IL, GA, VA. Netherlands, Argentina,
Product codes and lots: Catalog Number: DNPDG, Lot Number: NB0311 and NB0611

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2212-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2212-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-13

Product code HRS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)