Z-1186-2021Class II

Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

Name: Z-1186-2021 Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Creator: Howmedica Osteonics Corp.
Published: 2021-02-10
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2021-02-10 / Terminated / root cause: manufacturing process

FDA source

Howmedica Osteonics Corp. began a recall of Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer on 2021-02-10. FDA classified it as Class II and gives the reason as "Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1186-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-10
Posted: 2021-03-08
Terminated: 2023-05-30
Recalling firm: Howmedica Osteonics Corp
Product: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On 2/11/2021, Stryker issued Urgent Medical Device Recall notices to customers via UPS 2-day air stating Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized.
Quantity in commerce: 11 devices
Distribution: Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.
Product codes and lots: Catalogue # 5536-B-400, Lot Number CTD44301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1186-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1186-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-08

Product code MBH

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)