FDAClass IIApril 4, 2018

AltiVate Reverse INSTRUMENTATION recall

AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument.…

Why was AltiVate Reverse INSTRUMENTATION recalled?

Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.

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 Codes: 183312L03, 200006L01, 224643L01

Product
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument.…
Recalling firm
Encore Medical, Lp
Quantity
387 units
Distribution
US Nationwide Distribution
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls