Biomet Recalls Distal Radius Fracture Drill Guides Due to Jig Sticking
Biomet, Inc. is recalling 37 units of Distal Radius Fracture Repair System drill guides because they become stuck in the jig during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical defect in a surgical device that could compromise the procedure, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 37 units of the Distal Radius Fracture Repair System, specifically the Drill Guide DNP 3.3mm. The affected devices are identified by Catalog Number DNPDG and Lot Numbers NB0311 and NB0611. The recall is classified as Class II by the FDA.
The recall was initiated after the firm received complaints indicating that the drill guide becomes stuck in the jig. According to the source text, the drill guide can be placed in the jig about halfway before it becomes stuck. This mechanical issue may interfere with the proper use of the device during surgical procedures.
The product was distributed domestically to California, Pennsylvania, Iowa, Colorado, New York, Maryland, North Carolina, Alabama, Arizona, Illinois, Georgia, and Virginia, as well as internationally to the Netherlands and Argentina. Healthcare providers and facilities that have received these specific lot numbers should stop using the affected drill guides and contact Biomet, Inc. for instructions on return or replacement.
The recalled product
- 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
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 37
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number: DNPDG
- Lot Number: NB0311 and NB0611
Distribution
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