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Terminated

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

FDA Recall Z-2278-2019 · Posted None

Recalling FirmPega Medical Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2019-05-29
Date Terminated2021-01-15
Product Quantity19

Reason for Recall

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

Firm Action

An e-mail was sent on May 25, 2019 to all their consignees with the following instructions. Identify the device with the same catalogue number and lot number and return the device to Pega Medical Inc. as soon as possible to the address shown below using the FedEx Account number provided. Contact Enrique Garcia at (450) 688-5144 ext. 242 or [email protected] for more information

Root Cause

Component design/selection

Distribution Pattern

CA, DE, FL, IL, NC, NE, NY and TN

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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