Zimmer Biomet Recalls ECT Quick-Connect Drills Due to Fracture Risk
Zimmer Biomet is recalling 62 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to 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 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 poses a significant risk of injury to patients during procedures.
Plain-English summary
Zimmer Biomet, Inc. is recalling 62 units of ECT Internal Fracture Fixation Quick-Connect Drills (3.5 mm Diameter, 11 cm Length, Item Number 00241003500). 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 the instruments were manufactured from raw material containing an anomaly. This anomaly may be located on or below the surface of the instrument and can increase the risk of the instrument fracturing during use. The affected lot number is 63510893.
Healthcare facilities and distributors should stop using the affected instruments and contact Zimmer Biomet for instructions on return or replacement. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 62
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 (1)
- Lot Number: 63510893
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.
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