The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2746-2016·Announced 2016-09-14

Maquet Operating Room Table Connecting Bracket Recall for Welded Joint Failure

Maquet is recalling Connecting Bracket (Fixture) Devices because post-market surveillance reports indicate the welded joint between the square mount and the first fixable swivel joint is broken.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device used during surgical interventions. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling the Connecting Bracket (Fixture) Device (1002.65A0). This device is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during, and after surgical interventions, as well as for examination and treatment. The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount.

The recall was initiated due to 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 the device is broken. The agency has classified this recall as Class II.

A total of 19 units were distributed in the United States and 1,975 units were distributed outside the United States. The affected units were distributed nationwide to California, Florida, Iowa, Indiana, Missouri, Utah, and Wisconsin. The specific part number or catalog number associated with the recall is 1002.64A0.

The recalled product

Product
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to…
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Operating Room Table Accessories
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part Number/Catalog Number 1002.64A0

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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