Home / Recalls / Stryker Howmedica Osteonics Corp. / Z-2390-2016

Z-2390-2016 Class II Terminated

Recalled by Stryker Howmedica Osteonics Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
August 17, 2016
Initiation Date
June 23, 2016
Termination Date
August 1, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47 units

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.

Distribution Pattern

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

Code Information

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

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  • Z-0378-2017 Class II — LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF (August 29, 2016)
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  • Z-2377-2016 Class II — Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541 (June 23, 2016)