Recall Z-2390-2016— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2390-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-23

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2016-06-23, terminated 2018-08-01. It names one FDA 510(k) clearance: K123486. Product: 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. Reason: 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..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Terminated: 2018-08-01
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123486 — TRIATHLON TRITANIUM TIBIAL BASEPLATEStryker·cleared 2013-05-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.