CLASS II Device recall · Reported 28 Oct 2015 · FDA Enforcement Report

iTotal Posterior Stabilized Knee Replacement System- Itotal recalled

ConforMIS is recalling iTotal Posterior Stabilized Knee Replacement System- Itotal Ps-ipoly- Implant Kit-left, distributed nationwide in the US. The recall was initiated on 31 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers (US): Left: 0353417 0353616 0354944 0353554 0348951 0354052 0351267 0352723 0353063 0353116 0352223 0351354 0353685 0354118 0354573 0351678 0354306 0355213 0354531 0352895 0353969 0354670 0352804 0353375 0353584 0353955 0353394 0354457 0354251 0354470 0353392 0351881 0353596 0352702 0354028 0354049 0352925 0354005 0354115 0354863 0352181 0354089 0353451 0354720 0352945 0353262 0353662 0353269 Right:: 0353557 0354179 0350279 0355149 0353833 0353430 0353480 0353628 0354373 0352045 0353346 0350509 0352556 0353120 0353287 0353535 0354487 0354691 0351677 0354706 0353997 0354119 0353421 0353585 0353580 0353617 0354393 0354940 0353390 0353634 0353720 0354226 0353080 0353372 0353096 0354048 0354050 0354054 0354947 0353806 0354257 0354478 0354938 0355240 0354063 0352352 0353728 0353725 0354430 0353278 0353433 0353810 0352946 0353664 0353665 0354247 Serial Numbers: (OUS) iTOTAL PSIPOLYIMPLANT KIT LEFT 0352550 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353042 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353150 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353250 ITOTAL PSIPOLYIMPLANT KIT LEFT 0353544

Quantity recalled110 units

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-0147-2016
FDA event ID: 72108
Recalling firm: ConforMIS, Bedford, MA
Classification: Class II
Status: Terminated
Recall initiated: 31 Aug 2015
FDA classified: 21 Oct 2015
Reported: 28 Oct 2015
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

31 Aug 2015	Recall initiated by company
21 Oct 2015	Classified by FDA	+51 days
28 Oct 2015	Published in enforcement report	+7 days

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

Reason for recall

May contain small amounts of ethylene glycol residue

Product as listed by the FDA

ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111

Where it was distributed

Distributed Nationwide and in Germany, Switzerland, and UK.

Nationwide

Questions about this recall

Why was it recalled?

May contain small amounts of ethylene glycol residue

Which lots are affected?

Serial Numbers (US): Left: 0353417 0353616 0354944 0353554 0348951 0354052 0351267 0352723 0353063 0353116 0352223 0351354 0353685 0354118 0354573 0351678 0354306 0355213 0354531 0352895 0353969 0354670 0352804 0353375 0353584 0353955 0353394 0354457 0354251 0354470 0353392 0351881 0353596 0352702 0354028 0354049 0352925 0354005 0354115 0354863 0352181 0354089 0353451 0354720 0352945 0353262 0353662 0353269 Right:: 0353557 0354179 0350279 0355149 0353833 0353430 0353480 0353628 0354373 0352045 0353346 0350509 0352556 0353120 0353287 0353535 0354487 0354691 0351677 0354706 0353997 0354119 0353421 0353585 0353580 0353617 0354393 0354940 0353390 0353634 0353720 0354226 0353080 0353372 0353096 0354048 0354050 0354054 0354947 0353806 0354257 0354478 0354938 0355240 0354063 0352352 0353728 0353725 0354430 0353278 0353433 0353810 0352946 0353664 0353665 0354247 Serial Numbers: (OUS) iTOTAL PSIPOLYIMPLANT KIT LEFT 0352550 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353042 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353150 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353250 ITOTAL PSIPOLYIMPLANT KIT LEFT 0353544

Where was it sold?

Distributed Nationwide and in Germany, Switzerland, and UK.

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

10 other products · FDA event 72108

This product is part of a recall event; the main page for the event is iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral recalled.

Reported	Class	Recall	Company	Reason	Where
28 Oct 2015	CLASS II	iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral recalled	ConforMIS	Other	Nationwide
28 Oct 2015	CLASS II	iTotal CR Knee Replacement System- iTOTAL CR, Right Knee recalled	ConforMIS	Other	Nationwide
28 Oct 2015	CLASS II	iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial recalled	ConforMIS	Other	Nationwide
28 Oct 2015	CLASS II	iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral recalled	ConforMIS	Other	Nationwide
28 Oct 2015	CLASS II	iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral recalled	ConforMIS	Other	Nationwide
28 Oct 2015	CLASS II	iDuo Knee Bicompartmental Knee Replacement System , iDUO G2 recalled	ConforMIS	Other	Nationwide
28 Oct 2015	CLASS II	iTotal CR (Cruciate Retaining) Knee Replacement recalled by ConforMIS	ConforMIS	Other	Nationwide
28 Oct 2015	CLASS II	iTotal CR Knee Replacement System- Itotal CR - Ipoly recalled	ConforMIS	Other	Nationwide
28 Oct 2015	CLASS II	Unicondylar Knee Replacement System iUNI G2, Left Medial recalled	ConforMIS	Other	Nationwide
28 Oct 2015	CLASS II	iDUO G2, Right Lateral recalled by ConforMIS	ConforMIS	Other	Nationwide

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