Skip to content
Recall Observatory FDA recall evidence

Device product

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

Z-2317-2017

January 06, 2017

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 76023
Status
Terminated
Classification
Class II
Quantity
345
Official record key
device-enforcement:Z-2317-2017

Official wording

Reason: Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.

Code information: Unknown

Distribution pattern: Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.