Z-1419-2019 Class II Terminated
FDA device recall Z-1419-2019 was initiated by Zimmer GmbH on April 8, 2019 and is designated Class II. Reason for recall: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. The recall status is terminated (terminated May 11, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- April 8, 2019
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130
Reason for Recall
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Distribution Pattern
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
Code Information
All items marked with "Normed" are affected