Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 1,676 Pressure Sentinel Guide Wires because creases in the packaging seal may compromise sterility. The defect could increase the risk of infection during orthopaedic surgery.
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 medical device with a defect that compromises sterility, creating a risk of harm (infection) during surgery. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,676 units of the Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter (Item Number: 00-2228-024-00). The recall affects all lots expiring prior to September 30, 2023. The product is a single-use surgical instrument used during orthopaedic surgery for 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 compromises the product's sterility, which is critical for single-use surgical instruments to prevent the introduction of pathogens into the patient.
The affected products were distributed worldwide, including the United States, Canada, Australia, Brazil, Chile, Hong Kong, Japan, Malaysia, the Netherlands, Nicaragua, Singapore, and Taiwan. Healthcare providers and facilities should stop using these specific guide wires and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 1,676
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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Similar recalls
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