Device product

Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW

Z-0794-2019

November 16, 2018

Class III

Product summary

Firm: Ascension Orthopedics, Inc
Event: Event 81782
Status: Terminated
Classification: Class III
Quantity: Unavailable
Official record key: device-enforcement:Z-0794-2019

Official wording

Reason: The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).

Code information: 170691

Distribution pattern: Distributed to accounts in MO. Foreign distribution to Korea and Thailand.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).