Recall Z-2278-2019 ยท HSB Rod, Fixation, Intramedullary And Accessories
Pega Medical Inc.
SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
| Date | May 29, 2019 |
| Status | Terminated |
| Reason | Handle could jam with the Driver due to the detachment of an internal Connector Ring. |
| Root cause | Component design/selection |
| 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 egarcia@pegamedical.com for more information |
| Quantity | 19 |
| Distribution | CA, DE, FL, IL, NC, NE, NY and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143355 | The Simple Locking IntraMedullary (SLIM) System Pega Medical, Inc., Jul 10, 2015 |