CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
The Connecting Bracket (Fixture) Device recalled
Maquet Cardiovascular Us Sales is recalling The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element, distributed nationwide in the US. The recall was initiated on 12 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2746-2016
- FDA event ID
- 74915
- Recalling firm
- Maquet Cardiovascular Us Sales, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Aug 2016
- FDA classified
- 7 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 12 Aug 2016 | Recall initiated by company | |
| 7 Sep 2016 | Classified by FDA | +26 days |
| 14 Sep 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
Nationwide CaliforniaFloridaIowaIndianaMissouriUtahWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
Part Number/Catalog Number 1002.64A0
Where was it sold?
Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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