Agency classClass IIOur severity:High FDA (Devices)·Z-3174-2017·Announced 2017-10-04

Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk

Zimmer Biomet is recalling 173 nonsterile straight shank drill bits because raw material anomalies may increase the risk of instrument fracture 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 involves a risk-of-harm product (instrument fracture) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Zimmer Biomet, Inc. is recalling 173 units of Straight Shank Drill Bit 4.0 mm Diameter (Item Number/EDI 00231804000, Nonsterile). These orthopedic surgical instruments were distributed nationwide in the United States and internationally to Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan, and Trinidad.

The recall was initiated because various trauma and extremity instruments, including these drill bits and screw taps, were manufactured from raw material with an anomaly. This anomaly may be on or below the surface and can increase the risk of instrument fracture. The affected lot numbers are 63557051, 63451624, 63451625, 63451627, 63457895, 63517948, and 63524449.

Healthcare facilities and distributors should stop using these specific instruments and contact Zimmer Biomet for further instructions. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

Product: Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument.
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Surgical Instrument
Hazard: instrument-fracture
Affected units: 173

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 (6)

Lot Numbers: 63557051
63451624
63451625
63451627
63457895
63517948 & 63524449.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 60 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 60 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

See all →

High
Zimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
Moderate
Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
High
Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11

Same hazard · instrument fracture