Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-ROTATION SCREW 225708065 ITST ANTI-ROTATION SCREW 225708565 ITST ANTI-ROTATION SCREW 225709065 ITST ANTI-ROTATION SCREW Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Enforcement
- Recall Number
- Z-1138-2016
- Event ID
- 72900
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Manufacturing B.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 23, 2016
- Initiation Date
- January 11, 2016
- Classification Date
- March 12, 2016
- Termination Date
- April 13, 2017
- Address
- Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715, United States
Description
Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-ROTATION SCREW 225708065 ITST ANTI-ROTATION SCREW 225708565 ITST ANTI-ROTATION SCREW 225709065 ITST ANTI-ROTATION SCREW Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
lot no.: 62208147 62208146 62208148 62042715 62042716
US Nationwide Distribution
7