Laval, N/A, Canada
Pega Medical Inc. recalls
3 recalls recorded since 2018, most recently on 3 April 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 3 April 2020
- Terminated
- 20 November 2020
- Reason
- The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
- Distribution
- US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2038-2020
- 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.
Terminated Class II Medical devices
- Recall started
- 2 October 2019
- Terminated
- 26 October 2020
- Reason
- There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0270-2020
- SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Terminated Class II Medical devices
- Recall started
- 29 May 2019
- Terminated
- 15 January 2021
- Reason
- Handle could jam with the Driver due to the detachment of an internal Connector Ring.
- Distribution
- CA, DE, FL, IL, NC, NE, NY and TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2278-2019
- SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.