Zimmer Biomet Recalls Humeral Guide Wire Ball Tips Due to Packaging Seal Failure
Zimmer Biomet is recalling Humeral Guide Wire Ball Tips because the sterile packaging seal may fail, potentially compromising the device's 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 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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length (Item Number: 47-2255-008-00) due to a potential failure of the sterile packaging seal. The recall involves 19,483 units distributed nationwide in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad.
The recall is classified as Class II by the U.S. Food and Drug Administration. The specific hazard is that the sterile packaging seal may fail, which could result in the device not being sterile. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare providers and facilities should stop using the affected products and contact Zimmer Biomet for instructions on return or replacement. The affected lot numbers are: 63738593, 63738594, 63738595, 63738596, 63748395, 63748396, 63748397, 63748398, 63753767, 63753768, 63758425, 63758428, 63771163, 77006530, 77006531, 77006532, 77006533, 77006534, 77006535, 77006536, 77006537, 77006538, 77006539, 77006540, 77006541, 77006542, 77006543, 77006544, and 77006545.
The recalled product
- Product
- Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 19,483
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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