Z-2746-2016Class II

The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary...

Name: Z-2746-2016 The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2016-08-12
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2016-08-12 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table... on 2016-08-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2746-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-12
Posted: 2016-09-07
Terminated: 2017-05-04
Recalling firm: Maquet Cardiovascular Us Sales, LLC
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 adapt a range of different head and horseshoe head rests with a central square mount
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Use error
Action: Maquet sent an "Urgent Product Recall Medical Device Correction Letter and Medical Device Correction Response Form" dated August 12, 2016 via UPS to their affected customers. Customers were advised to inspect all devices that include the fixture for damage before every use. Customers were asked to fill out and sign the enclosed Medical Device Correction Response Form and return it via email to [email protected] or fax to 1-973-909-9927. Customers with questions were advised to contact their MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383. For questions regarding this recall call 973-709-7487.
Quantity in commerce: 19 units (US) and 1975 units (OUS)
Distribution: Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
Product codes and lots: Part Number/Catalog Number 1002.64A0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2746-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2746-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-07

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)