FDAClass IIOctober 28, 2015

AltiVate Humeral Socket Shell Trial recall

AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for…

Why was AltiVate Humeral Socket Shell Trial recalled?

Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.

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: 180052L01

Product
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for…
Recalling firm
Encore Medical, Lp
Quantity
20 units
Distribution
US Distribution to states of: PA, FL, ID, and CA.
Recall date
October 28, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls