FDA Medical Device Recalls (openFDA)
Pega Medical Inc.: SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
- Recall number
- Z-2278-2019
- Recalling firm
- Pega Medical Inc.
- Product
- SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
- Status
- Terminated
- Initiated
- 2019-05-29
- Posted
- not on file
- Terminated
- 2021-01-15
- 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
- Lot, serial or model codes
- Lot # 150115-09, 160427-01 and A162-02
- 510(k) numbers
- ["K143355"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3000327445
- Firm city
- Laval
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28