FDA Medical Device Recalls (openFDA)
Pega Medical Inc.: SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
- Recall number
- Z-0270-2020
- Recalling firm
- Pega Medical Inc.
- Product
- SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
- Status
- Terminated
- Initiated
- 2019-10-02
- Posted
- not on file
- Terminated
- 2020-10-26
- Reason
- 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
- 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: egarcia@pegamedical.com and Mr. Kildare Molina, at 450-688-5144 Ext. 267, Email: kildare@pegamedical.com.
- Quantity
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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