Pega Medical Recalls SLIM System Handle Due to Lot Number Mismatch
Pega Medical Inc. is recalling three units of the SLIM System handle because the lot number on the instrument does not match the packaging label.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences. The issue is a documentation/labeling mismatch with no reported injuries.
Plain-English summary
Pega Medical Inc. is recalling three units of the Orthopedic manual Surgical Instrument handle for the Simple Locking Intra Medullary (SLIM) System. The recall is due to a discrepancy where the lot number etched on the instrument handle does not match the lot number on the packaging label.
The affected product is the SLIM Handle with Catalog #SLM-HND100. The specific units have the etched lot code #B204-1 on the handle and Lot# B204-01 on the packaging label. The SLIM handle is used as the grip for the SLIM driver in orthopedic surgical procedures.
The recall covers US Nationwide Distribution, including Florida, with no foreign consignees listed. The source text does not report any illnesses or injuries associated with this labeling discrepancy.
The recalled product
- Product
- 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.
- Manufacturer
- Pega Medical Inc.
- Hazard
- Affected units
- 3
Distribution
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