Device recall: iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

FDA enforcement event 83760 · Class II · initiated 22 Aug 2019 · status Terminated · terminated 8 Jul 2020

DeviceVoluntary: Firm initiated2 product recordsBillerica, MA

FDA enforcement event 83760 is a device recall by Conformis, Inc. of Billerica, MA, initiated 22 Aug 2019 and classified Class II, with 2 product records.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 8 Jul 2020. Initiation: voluntary: firm initiated. Conformis, Inc. has 21 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Conformis, Inc., Billerica, MA.

Reason for recall

"Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging."

Distribution

"Distributed to consignees in MD and NV."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0063-2020	iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right	1	Class II	Terminated	16 Oct 2019
Z-0064-2020	iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right	1	Class II	Terminated	16 Oct 2019

Context

88%of 2019 device events are Class II968 events that year

2product records in this eventfirm median: 1

21events on this register for the firm

Other enforcement events for Conformis, Inc.

Initiated	Product (first record)	Type	Class	Records
25 Mar 2025	restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cor	Device	Class II	1
11 Mar 2024	Identity Imprint PS Tibial Tray Size 4: Lot 540287	Device	Class II	1
16 Jun 2023	CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO	Device	Class II	1
14 Nov 2022	iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE	Device	Class II	1
22 Feb 2022	iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101	Device	Class II	1
21 Sep 2020	iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replaceme	Device	Class II	1
20 Jul 2020	Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL C	Device	Class II	1
3 Feb 2020	iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage:	Device	Class II	2
25 Oct 2019	iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement Syst	Device	Class II	1
29 Mar 2019	Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)	Device	Class II	2

All 21 events for Conformis, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed to consignees in MD and NV."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 8 Jul 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.