FDAClass IIOctober 28, 2020

AltiVate Reverse Small Socket Insert recall: Labeling Error

AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices…

Why was AltiVate Reverse Small Socket Insert recalled?

Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.

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: 964W1000

Product
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices…
Recalling firm
Encore Medical, LP
Quantity
15
Distribution
US Nationwide distribution.
Recall date
October 28, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls