FDAClass IIIMay 27, 2020

Orthopedic manual Surgical Instrument handle for Simple recall

Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the…

Why was Orthopedic manual Surgical Instrument handle for Simple recalled?

The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.

Product
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the…
Recalling firm
Pega Medical Inc.
Quantity
3 units
Distribution
US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
Recall date
May 27, 2020
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls