—#128990

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

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K041081, K052248
Affected lot / code info: Catalog Number: DNPDG, Lot Number: NB0311 and NB0611

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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,

Timeline

Recall initiated: 2014-06-23
Posted by FDA: 2014-08-13
Terminated: 2015-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128990. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.