Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 2,080 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the packaging may compromise sterility.
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 medical device where a sterility compromise could lead to significant injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2,080 units of the Zimmer ZMS Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length (Item Number: 47-2237-033-00). These are single-use surgical instruments used during orthopaedic surgery for the 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. This defect may compromise the sterility of the product. The affected units are all lots expiring prior to September 30, 2023.
The product was 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 units and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 2,080
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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