Device product
Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.
Z-1000-2020
Product summary
- Event
- Event 84636
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-1000-2020
Official wording
Reason: The lot contained two outer pins instead of one outer and one inner pin.
Code information: Lot 64481139
Distribution pattern: Distributed to accounts in California and Ohio.
Derived failure modes
-
Unknown
The lot contained two outer pins instead of one outer and one inner pin.