Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 304 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.
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 (infection risk) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Zimmer Biomet, Inc. is recalling 304 units of 3.2MM X 510MM COCR THD TIP trauma guide wires (catalog number 14-443053). These medical devices are intended to be used as guide pins for the insertion of implants, such as cannulated screws and intramedullary nails, and for drilling bone.
The recall was initiated due to 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 units 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 source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- 3.2MM X 510MM COCR THD TIP; 14-443053 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
- 304
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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