FDAClass IIMarch 8, 2017

Total Joint Pack recall: Sterility Concern

Total Joint Pack, part number 006358-6

Why was Total Joint Pack recalled?

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

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 number and expiration date 84847, 2/28/2017 87391, 3/31/2017 89385, 6/17/2017 89960, 6/8/2017 94833, 6/26/2017 97859, 6/23/2017

Product
Total Joint Pack, part number 006358-6
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
14 kits
Distribution
Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
Recall date
March 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls