Z-0652-2022 Class II Terminated
FDA device recall Z-0652-2022 was initiated by Howmedica Osteonics Corp. on December 30, 2021 and is designated Class II. Reason for recall: There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. The recall status is terminated (terminated March 14, 2024). Affected quantity: 58 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 23, 2022
- Initiation Date
- December 30, 2021
- Termination Date
- March 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 devices
Product Description
Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
Reason for Recall
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
Distribution Pattern
The product was distributed to the following US states: MI
Code Information
GTIN: 04546540153296; Lot G7900352