Recall Z-2278-2019— Pega Medical Inc.

Name: FDA recall Z-2278-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-29

Class II · Terminated

Class II FDA medical device recall by Pega Medical Inc., initiated 2019-05-29, terminated 2021-01-15. It names one FDA 510(k) clearance: K143355. Product: SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System. Reason: Handle could jam with the Driver due to the detachment of an internal Connector Ring..

Recalling firm: Pega Medical Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-05-29
Terminated: 2021-01-15
Firm location: Laval, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K143355 — The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.·cleared 2015-07-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.