Z-0516-2018 Class II Terminated
FDA device recall Z-0516-2018 was initiated by Zimmer Biomet, Inc. on June 12, 2017 and is designated Class II. Reason for recall: A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture The recall status is terminated (terminated June 29, 2018). Affected quantity: 1,524 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- June 12, 2017
- Termination Date
- June 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,524 units
Product Description
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Reason for Recall
A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture
Distribution Pattern
AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland
Code Information
231220200 Item Number with the following Lot numbers 45785,46151, 47467, 48461, 48809, 100016 & 102325 231220202 Item Number with the following Lot Numbers: 45790, 48477, 48811, 100017, 101028 & 102338