FDA Medical Device Recalls (openFDA)
Biomet, Inc.: 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
- Recall number
- Z-2212-2014
- Recalling firm
- Biomet, Inc.
- 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
- Status
- Terminated
- Initiated
- 2014-06-23
- Posted
- 2014-08-13
- Terminated
- 2015-07-14
- 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.
- 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
- 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,
- Lot, serial or model codes
- Catalog Number: DNPDG, Lot Number: NB0311 and NB0611
- 510(k) numbers
- ["K041081","K052248"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28