Triathlon orthopaedic implant baseplate recalled for assembly defect
Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.
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: This is an FDA Class II medical device recall for a manufacturing defect affecting implant assembly and locking. While the defect poses a risk of implant failure, no injuries or illnesses have been reported, placing it in the High severity category.
Plain-English summary
Howmedica Osteonics Corp. is recalling the Triathlon Prim CEM FXD BPLT 7 orthopaedic implant baseplate (Catalog No. 5520B700, Lot JHS2H). This baseplate is a component of hip replacement implants used in orthopaedic surgery.
The internal profile of the baseplate is potentially oversized and may contain a witness mark (taper) at the bottom. This defect can prevent the insert from locking properly on the baseplate, compromising the structural integrity of the implant.
The affected lot was distributed nationwide in the United States (Arkansas, Colorado, Minnesota, Mississippi, New Jersey, Oklahoma, Pennsylvania, and Texas) as well as internationally to China and Italy. A total of 14 units were distributed in the US and 2 units outside the US.
Patients who have received this implant or physicians treating patients with this baseplate should contact Howmedica Osteonics for guidance. The company is working with healthcare providers to identify affected patients and coordinate appropriate follow-up care.
The recalled product
- Product
- Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
- Manufacturer
- Howmedica Osteonics Corp.
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)
- Lot JHS2H
Distribution
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