Z-0270-2020Class II

SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument...

Name: Z-0270-2020 SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument...
Creator: Pega Medical Inc.
Published: 2019-10-02
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2019-10-02 / Terminated / root cause: design

FDA source

Pega Medical Inc. began a recall of SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery on 2019-10-02. FDA classified it as Class II and gives the reason as "There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out". 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-0270-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-02
Posted: 2019-11-01
Terminated: 2020-10-26
Recalling firm: Orthopediatrics Canada ULC
Product: SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Root cause tag: design
FDA root cause: Device Design
Action: Pega Medical notified customers of the recall on about 10/02/2019, via "Urgent Field Safety Notice - Recall" letter. Customers were informed that SCFE Drivers, 6.5mm and 7.3 mm of the Free Gliding SCFE Screw System had issues with the knobs. Specifically the knobs have the potential to have loosened screws, or screws that have fallen out, as a result of the ultrasonic cleaning of the knobs. Customers were instructed to identify affected devices in inventory and return them to Pega Medical as soon as possible to address the issue. There returned devices can be returned via the FedEx information provided in the recall letter. Additionally customers were requested to provide the recall notification to all who need to be notified within your organization or any organization where the affected devices have been transferred. Contacts for questions include Mr. Enrique Garcia, at 450-688-5144 Ext 242, Email: [email protected] and Mr. Kildare Molina, at 450-688-5144 Ext. 267, Email: [email protected].
Quantity in commerce: 31 devices
Distribution: Nationwide distribution to CA, FL, GA, HI, LA, MA, MO, NC, NY, OK. International distribution to AUSTRALIA, CANADA, DENMARK, GERMANY, ISRAEL, MEXICO, ROMANIA, RUSSIA, UNITED ARAB EMIRATES, UNITED KINGDOM
Product codes and lots: Catalogue Numbers: SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373; Lot Numbers: 160428-03, 160428-04, A182-05, A182-15, 160603-05, 160603-06, A183-06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0270-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0270-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01

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)