Z-1806-2018 Class II Terminated
FDA device recall Z-1806-2018 was initiated by Zimmer Biomet, Inc. on August 7, 2017 and is designated Class II. Reason for recall: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surf… The recall status is terminated (terminated August 23, 2018). Affected quantity: 842 products in total.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- August 7, 2017
- Termination Date
- August 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 842 products in total
Product Description
Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
Reason for Recall
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.
Code Information
Lot 63683139, UDI (01)00889024246942(10)63683139; Lot 63613121, UDI (01)00889024246942(10)63613121