Stryker Orthopaedics Specialty Triathlon Tibial recall
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard…
Why was Stryker Orthopaedics Specialty Triathlon Tibial recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994
- Product
- Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard…
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 47 units
- Distribution
- Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
- Recall date
- August 17, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)