Z-2038-2020Class III

Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System -

Name: Z-2038-2020 Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System -
Creator: Pega Medical Inc.
Published: 2020-04-03
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2020-04-03 / Terminated / root cause: manufacturing process

FDA source

Pega Medical Inc. began a recall of Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver... on 2020-04-03. FDA classified it as Class III and gives the reason as "The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2038-2020
Classification: Class III
Status: Terminated
Initiated: 2020-04-03
Posted: 2020-05-15
Terminated: 2020-11-20
Recalling firm: Orthopediatrics Canada ULC
Product: Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 04/03/2020 Pega Medical Inc. sent out an email which included a Field Safety Notice letter to their US consignee identifying the problem, the actions to be taken by the customer/user in order to prevent risks for patients/users, and the actions planned by Pega Medical Inc. to correct the problem. PRODUCTS: The Handle of the Driver of the Simple Locking intramedullary System (SLIM) WITH CATALOG # SLM-HND100 which was distributed to the identified US consignee on 12/24/2019, with lot #8204-1 marked on the part (the driver handle) and with packaging labeled with lot# 8204-01. ACTION TO BE TAKEN BY THE CUSTOMER/USER: "Identify the device with the same catalogue number and lot number "Verify and correct any record on your files that may indicate the lot number of this part. The lot indicated in the records must be 8204-1. "If the part is still in its original package: Place provided label over the previous label making sure that all the information in the previous label is completely hidden. "If the part is not in its original package: No further action is required.
Quantity in commerce: 3 units
Distribution: US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
Product codes and lots: SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2038-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2038-2020	Class III	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-15

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)