Z-0371-2017 Class II Terminated
FDA device recall Z-0371-2017 was initiated by Schaerer Medical USA Inc on September 27, 2016 and is designated Class II. Reason for recall: The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak. The recall status is terminated (terminated July 17, 2020). Affected quantity: 4 surgical tables with defective floor locking cylinders were distributed. Each table contains 3 cylinders for a total .
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2016
- Initiation Date
- September 27, 2016
- Termination Date
- July 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 surgical tables with defective floor locking cylinders were distributed. Each table contains 3 cylinders for a total of 12 cylinders.
Product Description
The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
Reason for Recall
The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed
Code Information
Lot Codes for the four (4) model 7300 Surgical Tables TFX-1653, TFX1654, TFX1655, TFX1656