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
This recall has been terminated (originally issued August 12, 2016).
- Recall Initiated
- August 12, 2016
- Terminated
- May 4, 2017
- Recall Number
- Z-2746-2016
- Quantity
- 19 units (US) and 1975 units (OUS)
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
Lot / Code Info
Part Number/Catalog Number 1002.64A0
Root Cause
Use error
Action Taken
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 FieldAction@maquet.com 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.