Zimmer Biomet Recalls ECT Internal Fixation Drill Bits Due to Fracture Risk

Plain-English summary

Zimmer Biomet, Inc. is recalling ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. The recall involves 2,240 units of these orthopedic surgical instruments. The affected products 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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and facilities should stop using the affected drill bits and contact Zimmer Biomet for further instructions. Consumers who have purchased these items should contact the manufacturer for a refund or replacement. The specific lot numbers affected are listed in the official recall documentation.

The recalled product

Product

ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument.

Manufacturer

Zimmer Biomet, Inc.

Category

Medical Device — Orthopedic Surgical Instrument

Hazard

• instrument-fracture

Affected units

2,240

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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