Zimmer Biomet Recalls Orthopedic Surgical Instruments Due to Material Anomaly
Zimmer Biomet is recalling 173 orthopedic surgical instruments because a material anomaly 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.
Plain-English summary
Zimmer Biomet, Inc. is recalling 173 units of the Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D. (Item Number/EDI 00236017127, 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 is being conducted 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. The affected lot numbers are 63545430, 63578497, 63586028, 63606286, 63610624, 63635345, 63458048, 63469766, 63475222, and 63530224.
Healthcare facilities and distributors should stop using the affected instruments and contact Zimmer Biomet for further instructions. Consumers should not use these medical devices and should contact their healthcare provider or the manufacturer if they have questions regarding the recall.
The recalled product
- Product
- Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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 (9)
- Lot Numbers: 63545430
- 63578497
- 63586028
- 63606286
- 63610624
- 63635345
- 63458048
- 63469766
- 63475222 & 63530224.
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 →Related recalls
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