Zimmer Biomet Recalls Smooth Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling Smooth Guide Wires because creases in the sealing area may compromise product sterility. The recall affects 48,320 units distributed worldwide.
What this means for you
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 (sterility compromise in a surgical instrument) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length (Item Number: 47-2255-008-01). The recall is due to creases in the sealing area on the end opposite of the product's chevron opening, which may compromise the product's sterility.
The affected product is a single-use surgical instrument used during orthopaedic surgery for the implantation of a prosthesis. The recall covers 48,320 units with all lots expiring prior to September 30, 2023. The products were distributed nationwide in the United States and in Canada, Australia, Brazil, Chile, Hong Kong, Japan, Malaysia, the Netherlands, Nicaragua, Singapore, and Taiwan.
Healthcare providers should stop using the affected guide wires and contact Zimmer Biomet for further instructions. Consumers are not expected to have these products in their homes, as they are single-use surgical instruments.
The recalled product
- Product
- Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 48,320
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 (2)
- All lots expiring prior to September 30
- 2023
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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