Z-0661-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- October 5, 2018
- Termination Date
- March 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,250 units total
Product Description
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Reason for Recall
Potential for leakage due to defect in the thermoset check valve component.
Distribution Pattern
United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO, MS, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY
Code Information
Item number:41412-01. Lot number (UDI): 3591489 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3591489); 3598125 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3598125); 3608570 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3608570); 3610798 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3610798); 3618041 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3618041); 3656677 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3656677); 3665611 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3665611). Expiration Date 01/01/2021.