Zimmer Biomet Recalls Orthopedic Surgical Drills and Screw Taps
Zimmer Biomet is recalling 1,129 orthopedic surgical drills and screw taps due to raw material anomalies that may increase the risk of 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 meets the criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,129 units of the Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter (Item Number/EDI 00236020527) and various trauma and extremity instruments, including drill bits and screw taps. The affected products are nonsterile orthopedic surgical instruments.
The recall was initiated because the instruments 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 63557936, 63566282, 63574978, and 63623144.
The 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. Healthcare facilities and distributors should stop using the affected instruments and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item Number/EDI 00236020527, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,129
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 (3)
- Lot Numbers: 63557936
- 63566282
- 63574978 & 63623144.
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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