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Recall Observatory FDA recall evidence

Device product

SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

Z-2278-2019

May 29, 2019

Class II

Product summary

Firm
Pega Medical Inc.
Event
Event 83372
Status
Terminated
Classification
Class II
Quantity
19
Official record key
device-enforcement:Z-2278-2019

Official wording

Reason: Handle could jam with the Driver due to the detachment of an internal Connector Ring.

Code information: Lot # 150115-09, 160427-01 and A162-02

Distribution pattern: CA, DE, FL, IL, NC, NE, NY and TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Handle could jam with the Driver due to the detachment of an internal Connector Ring.