[pending] Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size
Pending LLM rewrite. Source: FDA_DEVICE Z-0418-2026.
What this means for you
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: Pending LLM scoring against the rubric.
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., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; 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)00889024572706(17)300406(10)67160447
- Lot Number 67160447
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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