Pega Medical Inc. recalls Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM…
- Recall date
- April 3, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2038-2020
- FDA classification
- Class III
- Brand / firm
- Pega Medical Inc.
- Sold / distributed
- US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
Why it was recalled
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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