Stryker Recalls Mislabelled Triathlon Tibial Inserts for Knee Replacement
Stryker Howmedica Osteonics is recalling 26 Triathlon tibial inserts because one unit was found in a package labeled for a different catalog number.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a risk of temporary or medically reversible health consequences. The hazard is a labeling error (mis-labeling) where a device was packaged with the wrong catalog number, which is a moderate risk if the wrong implant is used, but no injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 26 units of Triathlon PS X3 and Triathlon TS Plus Tibial Inserts. These medical devices are used in total knee arthroplasty (TKA) surgeries as the bearing component for the articulating surface of the femoral component.
The recall was initiated after Stryker Orthopaedics received a report that a 5537-G-319 No 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm was found in a package labeled as a 5532-G-511 Triathlon PS Tibial Insert. This indicates a labeling error where the physical product did not match the catalog number on the packaging.
The affected units are identified by Catalog Number 5532-G-511 (Lot LD8D7Y) and Catalog Number 5537-G-319 (Lot TT6JT2). The products were distributed worldwide and nationwide in the US. Healthcare providers and facilities should check their inventory for these specific catalog numbers and lot numbers and stop using the affected devices.
The recalled product
- Product
- Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, t
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number 5532-G-511 Lot LD8D7Y Catalog Number 5537-G-319 Lot TT6JT2
Distribution
Distributed nationwide across the United States.
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