CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report

Responsive, Knee: Femoral total knee replacement Component recalled

Medtronic Sofamor Danek USA is recalling Responsive, Knee: Femoral total knee replacement Component CR/CS, Size 4R, distributed in Arkansas, Massachusetts, Minnesota. The recall was initiated on 18 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesP239150

Quantity recalled3

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2632-2016
FDA event ID: 74850
Recalling firm: Medtronic Sofamor Danek USA, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2016
FDA classified: 23 Aug 2016
Reported: 31 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

18 Jul 2016	Recall initiated by company
23 Aug 2016	Classified by FDA	+36 days
31 Aug 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

Product as listed by the FDA

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,

Where it was distributed

AR, MN,MA

Arkansas Massachusetts Minnesota

Questions about this recall

Why was it recalled?

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

Which lots are affected?

P239150

Where was it sold?

AR, MN,MA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 74850

This product is part of a recall event; the main page for the event is Tibial Tray , Size recalled by Medtronic Sofamor Danek USA.

Reported	Class	Recall	Company	Reason	Where
31 Aug 2016	CLASS II	Tibial Tray , Size recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Other	AR, MA, MN
31 Aug 2016	CLASS II	Tibial Tray , Size recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Other	AR, MA, MN
31 Aug 2016	CLASS II	Responsive, Knee: Femoral total knee replacement Component recalled	Medtronic Sofamor Danek USA	Other	AR, MA, MN
31 Aug 2016	CLASS II	Tibial Tray , Size recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Other	AR, MA, MN
31 Aug 2016	CLASS II	Responsive, Knee: Femoral Component Cr/cs, Size 3r recalled	Medtronic Sofamor Danek USA	Other	AR, MA, MN
31 Aug 2016	CLASS II	Tibial Tray , Size recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Other	AR, MA, MN
31 Aug 2016	CLASS II	Responsive, Knee: Femoral total knee replacement Component recalled	Medtronic Sofamor Danek USA	Other	AR, MA, MN

More recalls from Medtronic Sofamor Danek USA

All 77

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS II	Catalyft PL & PL40 Expandable Interbody System labeled as recalled	Medtronic Sofamor Danek USA	Other	Nationwide
1 Nov 2023Device	CLASS II	Grafton DBM Crunch recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Matrix Strips recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Putty recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton Plus DBM Paste recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide