FDAClass IISeptember 2, 2020

ALTERA Spacer ALTERA Spacer recall

ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿

Why was ALTERA Spacer ALTERA Spacer recalled?

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

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?

Part #: 1124.1133; Lot # / UDI #: BAX108TE / (01)00889095069754(10)BAX108TE; BAX178ME / (01)00889095069754(10)BAX178ME; BAX208TE / (01)00889095069754(10)BAX208TE; BAX299NE / (01)00889095069754(10)BAX299NE; BAX413CE / (01)00889095069754(10)BAX413CE; BAX413GE / (01)00889095069754(10)BAX413GE

Product
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
Recalling firm
Globus Medical, Inc.
Quantity
N/A
Distribution
Worldwide Distribution
Recall date
September 2, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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