Stryker Recalls Triathlon Knee Baseplates Due to Manufacturing Defect
Stryker is recalling 11 Triathlon Tritanium Tibial Baseplates because a manufacturing defect may prevent the knee insert from locking securely.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device that prevents a critical locking mechanism from functioning, posing a risk of harm, but the source text does not report any injuries or illnesses.
Plain-English summary
Stryker has initiated a recall of 11 units of the Triathlon Tritanium Tibial Component (Baseplate), size 4. The affected devices are identified by Catalogue # 5536-B-400 and Lot Number CTD44301. These devices were distributed to facilities in Arizona, Georgia, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, Oregon, Pennsylvania, South Carolina, Utah, Washington, and West Virginia.
The recall was issued because Stryker discovered that the internal profile of the baseplate is potentially oversized due to a manufacturing issue. Specifically, a witness mark or taper may be present at the bottom of the internal profile. This defect prevents the insert from locking onto the baseplate, which is a critical function for the stability of the knee prosthesis.
Healthcare providers and patients who have received or used these specific devices should contact Stryker or their medical provider for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 11
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 (2)
- Catalogue # 5536-B-400
- Lot Number CTD44301
Distribution
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