FDA-Device2020-05-27Class III
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.
Pega Medical Inc.
Hazard
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Sold states
US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
Affected count
3 units
Manufactured in
1111 Chomedey (A-13) E, N/A, Laval, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2038-2020Don't want to check this manually?
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