Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drill Bits
Zimmer Biomet is recalling 10 units of ECT Internal Fracture Fixation Quick-Connect Drills due to a raw material anomaly that may increase the risk of instrument fracture during use.
What this means for you
Illness, injury, or structural failure has been reported. 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 (risk of 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 FDA Class II with potential for serious harm).
Plain-English summary
Zimmer Biomet, Inc. is recalling 10 units of ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length (Item Number/EDI 00241004000, Nonsterile). The affected 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 specific lot number for the recalled units is 63518082.
The recall was initiated because the drill bits and screw taps were manufactured from raw material with an anomaly. This anomaly may be on or below the surface of the instrument and can increase the risk of the instrument fracturing during use. The FDA has classified this recall as Class II, indicating a situation where 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 facilities and distributors should stop using the affected instruments immediately. Consumers and medical professionals should contact Zimmer Biomet for instructions on returning the product or obtaining a replacement. No specific instructions for end-users are provided in the source text beyond the standard recall notification.
The recalled product
- Product
- ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 10
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: 63518082
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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