FDAClass IINovember 4, 2015

Turon Shoulder Impaction Fixture recall

Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the…

Why was Turon Shoulder Impaction Fixture recalled?

During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

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 # 52748L02A

Product
Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the…
Recalling firm
Encore Medical, Lp
Quantity
277 units
Distribution
Nationwide Distribution
Recall date
November 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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