Agency classClass IIOur severity:Severe FDA (Devices)·Z-3180-2017·Announced 2017-10-04

Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk

Zimmer Biomet is recalling 1,091 nonsterile orthopedic surgical drills and screw taps because raw material anomalies may cause instrument fracture.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (instrument fracture) in a surgical device, which aligns with the rubric criteria for Severe severity (structural vehicle defect or significant injury/property-damage reports, or high-risk medical device defects).

Plain-English summary

Zimmer Biomet, Inc. is recalling 1,091 units of the Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter (Item Number/EDI 00236017520). These nonsterile 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 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 during use. The affected lot numbers are 63599481, 63461425, 63469758, 63475225, and 63481881.

Healthcare facilities and distributors should stop using these instruments and contact Zimmer Biomet for instructions on return or replacement. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical instrument.
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Surgical Instrument
Hazard: instrument-fracture
Affected units: 1,091

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 (4)

Lot Numbers: 63599481
63461425
63469758
63475225 & 63481881.

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.

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Same hazard · instrument fracture