Z-1515-2017Class II

Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR...

Name: Z-1515-2017 Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2017-02-20
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2017-02-20 / Terminated

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR... on 2017-02-20. FDA classified it as Class II and gives the reason as "The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1515-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Posted: 2017-03-21
Terminated: 2017-10-27
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10, REF 90-SRK-160410 e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 h) Poly Component Trial - CR 5x12, REF 90-SRK-160512 i) Poly Component Trial - CR 5x14, REF 90-SRK-160514 j) Poly Component Trial - CR 6x10, REF 90-SRK-160610 k) Poly Component Trial - CR 6x12, REF 90-SRK-160612 l) Poly Component Trial - CR 6x14, REF 90-SRK-160614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
FDA root cause: Under Investigation by firm
Action: Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197.
Distribution: US distribution to AR, MA
Product codes and lots: Lot Numbers: a) REF 90-SRK-160310, TU53730-01 b) REF 90-SRK-160312, TU53731-01 c) REF 90-SRK-160314, TU53732-01 d) REF 90-SRK-160410, TU53730-02 e) REF 90-SRK-160412, TU53731-02 f) REF 90-SRK-160414, TU53732-02 g) REF 90-SRK-160510, TU53730-03 h) REF 90-SRK-160512, TU53731-03 i) REF 90-SRK-160514, TU53732-03 j) REF 90-SRK-160610, TU53730-04 k) REF 90-SRK-160612, TU53731-04 l) REF 90-SRK-160614, TU53732-04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1515-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1513-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1514-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1515-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21
Z-1516-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21

Product code JWH

K150496Class IITotal Knee Arthroplasty SystemResponsive Orthopedics, LLC / cleared 2015-06-12

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)