Device product
Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
Z-1807-2018
Product summary
- Event
- Event 79991
- Status
- Terminated
- Classification
- Class II
- Quantity
- 842 products in total
- Official record key
device-enforcement:Z-1807-2018
Official wording
Reason: 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.
Code information: Lot 63693589, UDI (01)00889024247574(10)63693589; Lot 63649575, UDI (01)00889024247574(10)63649575; Lot 63576035, UDI (01)00889024247574(10)63576035; Lot 63531869, UDI (01)00889024247574(10)63531869
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.
Derived failure modes
-
Unknown
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.