Z-2637-2016Class II

TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

Name: Z-2637-2016 TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Creator: Medtronic Sofamor Danek USA Inc
Published: 2016-07-18
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2016-07-18 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement on 2016-07-18. FDA classified it as Class II and gives the reason as "The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler". 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-2637-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-18
Posted: 2016-08-23
Terminated: 2016-11-22
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 07/18/2016, the firm initiated the correction by verbally notifying (by visit and telephone) three of four (3 of 4) implanting surgeons; the fourth implanting surgeon was verbally notified on 07/25/2016. The firm followed with a letter to all four (4) surgeons on 07/28/2016. Medtronic recommended that the condition of the patients receiving the subject part be assessed for any indications of premature failure during normal post-operative follow-up visits.
Quantity in commerce: 2 units
Distribution: AR, MN,MA
Product codes and lots: P239168, P239169

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2637-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2631-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2632-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2633-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2634-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2635-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2636-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2637-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2638-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23

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)