Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 11 trauma guide wires due to packaging defects that may compromise sterility, posing an infection risk.
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 agency classification is FDA Class II, and the source text explicitly identifies a 'possible risk for infection' due to sterile barrier failure, which aligns with the rubric criteria for Severe severity involving significant injury reports or high-risk medical device defects.
Plain-English summary
Zimmer Biomet, Inc. is recalling 11 units of various trauma guide wires, including the G-PIN 2.8BL 3.2PL 98CM 2PK and NL DRIVING GUIDE 4.4MM X 80CM. These devices are intended to be used as guide pins for the insertion of implants such as cannulated screws and intramedullary nails, as well as for drilling bone.
The recall was initiated because of insufficient packaging design verification and an occurrence rate of complaints for sterile barrier failure that exceeded expected levels. Guide wires packaged in the affected configuration have the potential for sterile barrier breach, which creates a possible risk for infection.
The affected products were distributed worldwide, including nationwide in the United States and in Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and the Netherlands. The specific codes associated with the recall are 143206 and 281765. Healthcare facilities and consumers should check their inventory for these specific product codes and packaging configurations and stop using the affected devices.
The recalled product
- Product
- G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 11
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)
- 143206 281765
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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