FDAClass IIJuly 11, 2018

Cannulated Driver Handle recall: Impurity Out of Spec

Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile

Why was Cannulated Driver Handle recalled?

Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.

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?

Lot: 603599

Product
Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
Recalling firm
Trilliant Surgical Ltd.
Quantity
94
Distribution
U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO
Recall date
July 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls