Z-2329-2021Class II

Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

Name: Z-2329-2021 Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Creator: Howmedica Osteonics Corp.
Published: 2021-07-01
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2021-07-01 / Terminated

FDA source

Howmedica Osteonics Corp. began a recall of Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 on 2021-07-01. FDA classified it as Class II and gives the reason as "The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2329-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-01
Posted: 2021-08-19
Terminated: 2023-05-17
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.
FDA root cause: Under Investigation by firm
Action: On July 1, 2021, the firm notified customers via Urgent Medical Device Recall. The letter listed the hazards and harms potentially associated with the recalled product and also listed mitigation factors. Patients treated with an affected product should continue to be followed per the normal protocol established by his or her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. It should be noted that the failure of the insert to fully seat, may not be evident on x-ray unless the insert has dislodged. Actions Needed: Our records indicate that you may have received the affected product(s). It is Strykers responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important follow up communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. Customers should complete and sign the included customer response form and return it to the recalling firm. Hospitals should contact their local sales office or Stryker sales representative directly for product returns and inventory questions. Customers who have further distributed the product should forward should notify downstream accounts and return all affected devices to the recalling firm. For questions pertaining to the recall, please contact Customer Service at (201) 831-5000, or email [email protected]
Quantity in commerce: 14 US; 2 OUS
Distribution: Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.
Product codes and lots: Lot JHS2H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2329-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2329-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-19

Product code JWH

K141056Class IITriathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics / cleared 2014-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)