Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2016 - (Recall #: Z-2390-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants

Product Classification:

Class II

Date Initiated: June 23, 2016

Date Posted: August 17, 2016

Recall Number: Z-2390-2016

Event ID: 74619

Reason for Recall:

It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.

Status: Terminated

Product Quantity: 47 units

Code Information:

Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994

Distribution Pattern:

Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT

Voluntary or Mandated:

Voluntary: Firm initiated