Z-0137-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2015
- Initiation Date
- August 6, 2015
- Termination Date
- October 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Reason for Recall
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Distribution Pattern
Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
Code Information
Lot Code # 101465 Model # 19-5000