SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
This recall has been terminated (originally issued May 29, 2019).
- Recall Initiated
- May 29, 2019
- Terminated
- January 15, 2021
- Recall Number
- Z-2278-2019
- Quantity
- 19
- Official Source
- View on FDA website ↗
Reason for Recall
Handle could jam with the Driver due to the detachment of an internal Connector Ring.
Distribution
CA, DE, FL, IL, NC, NE, NY and TN
Lot / Code Info
Lot # 150115-09, 160427-01 and A162-02
Root Cause
Component design/selection
Action Taken
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 egarcia@pegamedical.com for more information