Z1 Femoral Hip System Recalled Over Stem Inserter Design Issue
Zimmer, Inc. is recalling 35 units of the Z1 Femoral Hip System due to a potential design issue with the Z1 Offset Stem Inserter that could cause fracturing of the distal tip.
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: This is a Class II medical device recall for a hip implant with a potential design issue that could lead to fracturing of the distal tip. No hospitalizations, injuries, or deaths have been reported, placing it in the 'High' category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Z1 Femoral Hip System (Product Number 611777612) manufactured by Zimmer, Inc. is being recalled due to a potential design issue with the Z1 Offset Stem Inserter that could cause fracturing of the distal tip.
Thirty-five units of this product have been distributed nationwide in the United States. The affected units can be identified by UDI-DI 00887868577888 and lot numbers 102646, 102777, 102778, 104095, 104324, and 105277.
This is a Class II medical device recall.
The recalled product
- Product
- Z1 Femoral Hip System, Product Number 611777612
- Manufacturer
- Zimmer, Inc.
- Category
- Medical Device — Hip Implant
- Hazard
- Affected units
- 35
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)
- UDI-DI: 00887868577888
- Lot Numbers: 102646 102777 102778 104095 104324 105277
Distribution
Distributed nationwide across the United States.
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