Z-0165-2016Class II

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in...

Name: Z-0165-2016 Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in...
Creator: Encore Medical, Lp
Published: 2015-09-16
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2015-09-16 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella on 2015-09-16. FDA classified it as Class II and gives the reason as "The labeling is missing the size/diameter information". 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-0165-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-16
Posted: 2015-10-26
Terminated: 2016-01-04
Recalling firm: Encore Medical, LP
Product: Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
Product code: OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Reason for recall: The labeling is missing the size/diameter information.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.
Quantity in commerce: 209 units
Distribution: US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.
Product codes and lots: 471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0165-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0165-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-26

Product code OIY

K140830Class IIExprt Revision KneeEncore Medical L.P. / cleared 2014-07-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)