Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size
Pending LLM rewrite. Source: FDA_DEVICE Z-0419-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The recalled product
- Product
- Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
- Manufacturer
- Zimmer, Inc.
- Category
- Medical Device — Devices
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 (01)00889024572713(17)300406(10)67160480
- Lot Number 67160480
Distribution
Distributed in 20 states:
- AL
- AZ
- CA
- FL
- GA
- IA
- IL
- KS
- MD
- MI
- NC
- NE
- NM
- NY
- OH
- PA
- TN
- TX
- WA
- WI
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