Z-2278-2019Class II

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

Name: Z-2278-2019 SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
Creator: Pega Medical Inc.
Published: 2019-05-29
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2019-05-29 / Terminated / root cause: design

FDA source

Pega Medical Inc. began a recall of SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System on 2019-05-29. FDA classified it as Class II and gives the reason as "Handle could jam with the Driver due to the detachment of an internal Connector Ring". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2278-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-29
Posted: 2019-08-14
Terminated: 2021-01-15
Recalling firm: Orthopediatrics Canada ULC
Product: SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Handle could jam with the Driver due to the detachment of an internal Connector Ring.
Root cause tag: design
FDA 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 [email protected] for more information
Quantity in commerce: 19
Distribution: CA, DE, FL, IL, NC, NE, NY and TN
Product codes and lots: Lot # 150115-09, 160427-01 and A162-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2278-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2278-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14

Product code HSB

K143355Class IIThe Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. / cleared 2015-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)