Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 780 Humeral Guide Wires because creases in the packaging may compromise sterility. The product is a single-use surgical instrument.
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 is classified as FDA Class II. The hazard involves a potential compromise to sterility in a surgical instrument, which presents a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 780 units of the Zimmer M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length (Item Number: 00-2255-026-00). The recall affects all lots expiring prior to September 30, 2023. The product is a single-use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
The recall was initiated because creases were found in the sealing area on the end opposite of the product's chevron opening. These creases may compromise the sterility of the product. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected products were distributed worldwide, including in the United States, Canada, Australia, Brazil, Chile, Hong Kong, Japan, Malaysia, the Netherlands, Nicaragua, Singapore, and Taiwan. Healthcare facilities and distributors should stop using the affected guide wires and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 780
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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