Z-1512-2018Class II

Knee Prosthesis, Sterile, Single-Use devices

Name: Z-1512-2018 Knee Prosthesis, Sterile, Single-Use devices
Creator: Howmedica Osteonics Corp.
Published: 2018-01-12
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2018-01-12 / Terminated / root cause: labeling and UDI

FDA source

Howmedica Osteonics Corp. began a recall of Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain... on 2018-01-12. FDA classified it as Class II and gives the reason as "Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1512-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Posted: 2018-04-24
Terminated: 2020-05-07
Recalling firm: Howmedica Osteonics Corp
Product: Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Branches/Agencies notified by email on 01/16/2018 and were asked to quarantine affected devices. Notification letters and product accountability forms were sent via UPS (with return receipt) on 01/15/2018. Customer notifications were updated and sent to consignees on 03/16/2018 as the technical and medical assessments associated with the issue were completed and additional information related to potential hazards and harms were identified.
Quantity in commerce: 6 units of catalog 5521-B-400
Distribution: Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
Product codes and lots: Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1512-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1512-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24

Product code MBH

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)