FDAClass IISeptember 14, 2016

The Connecting Bracket recall

The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room…

Why was The Connecting Bracket recalled?

Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken.

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 Number/Catalog Number 1002.64A0

Product
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room…
Recalling firm
Maquet Cardiovascular Us Sales, Llc
Quantity
19 units (US) and 1975 units (OUS)
Distribution
Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
Recall date
September 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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