Z-1186-2021 Class II Terminated
FDA device recall Z-1186-2021 was initiated by Howmedica Osteonics Corp. on February 10, 2021 and is designated Class II. Reason for recall: Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there m… The recall status is terminated (terminated May 30, 2023). Affected quantity: 11 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 17, 2021
- Initiation Date
- February 10, 2021
- Termination Date
- May 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 devices
Product Description
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Reason for Recall
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
Distribution Pattern
Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.
Code Information
Catalogue # 5536-B-400, Lot Number CTD44301