Use caution Medical device recall · FDA · Published March 29, 2019

Conformis iTotal Hip Replacement System Recall: 3mm Neck/Head Length Discrepancy Risk

Conformis recalls specific hip replacement stems due to 3mm discrepancy between iViews measurements and actual implant neck/head lengths, potentially causing improper fit.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1775-2019Medical device Conformis ›

Use caution until it’s fixed

Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.

Take action

Contact the company

Recalling firmConformis, Inc.600 Technology Park Dr · Billerica, MA 01821-4154

✎ GovInfoNow plain-language explainer

Conformis is recalling certain hip replacement stems (HBS-033-00xx-010101) because the measured neck/head lengths in the implants differ by 3mm from what surgeons approved. This could lead to improper fit during surgery, risking complications. Read more at govinfonow.com/recall/68535-conformis-itotal-hip-replacement-system-recall-3mm-neck-head-length.

Source Summary by GovInfoNow · govinfonow.com/recall/68535-conformis-itotal-hip-replacement-system-recall-3mm-neck-head-length · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1775-2019

Cite this page

“Conformis iTotal Hip Replacement System Recall: 3mm Neck/Head Length Discrepancy Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68535-conformis-itotal-hip-replacement-system-recall-3mm-neck-head-length. Based on FDA recall #Z-1775-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1775-2019%22&limit=1).

Conformis Inc. recalled Conformis iTotal Hip Replacement System implants due to a discrepancy between displayed and actual neck/head lengths, according to the FDA on March 29, 2019.

How to tell if you have it

Brand: Conformis
Product: iTotal Hip Replacement System (HIP-PATIENT SPECIFIC STEM LEFT)
Model/Part Numbers: HBS-033-00xx-010101, HBS-033-0010-010101, HBS-033-0011-010101, HBS-033-0012-010101, HBS-033-0013-010101, HBS-033-0014-010101, HBS-033-0015-010101, HBS-033-0016-010101
Serial Numbers: 423398, 424244, 424392, 425455, 425607, 425755, 426309, 427186, 428901, 430404, 430766, 431394, 431844, 434871, 436520, 438363, 438925, 439064, 439561, 440369, 441662, 441734, 422796, 424450, 424510, 426034, 426118, 430150, 430534, 431142, 431502, 431581, 432030, 433555, 434136, 434439, 435282, 436108, 436212, 437452, 437657, 437745, 437968, 440603, 442816, 425346, 425608, 425866, 427702, 427754, 429459, 429844, 430053, 430087, 432011, 432363, 436792, 437653, 438516, 439063, 440253, 422797, 424647, 425456, 426297, 427360, 427898, 428372, 428957, 429014, 429921, 429937, 430338, 430613, 430962, 433445, 434149, 434451, 434635, 435118, 436125, 436230, 436333, 437073, 438024, 438112, 439641, 439929, 441028, 441030, 423231, 425276, 426069, 426382, 427480, 427752, 427883, 428820, 428900, 431315, 431333, 431977, 432543, 432953, 434612, 435649, 435883, 435910, 436122, 437322, 437863, 438631, 440445, 429552, 432936, 433085, 437373, 437681, 437925, 439272, 425418, 428545, 431199, 435657, 436790, 437425, 437656, 442745
Quantity: 128 units

The hazard

The recall involves a 3mm discrepancy between the neck/head lengths displayed and approved by surgeons in iViews and the resulting lengths in the manufactured implants, according to the FDA.

Context

GovInfoNow's records show Conformis Inc. has 14 other recalls on record since July 24, 2017. Other recent recalls of similar products include Conformis Hip System Acetabular Liner Recalled Due to Incorrect Labeling (March 25, 2025), Conformis Identity Imprint PS Tibial Tray Size 4 Lot 540287: Packaging Mix-Up Risk (March 11, 2024), and Conformis Hip Screw Recall: 30mm screws labeled as 25mm (June 16, 2023). Other recent recalls of similar products include Straumann Bone Level Tapered Implant May Be Wrong Length (July 16, 2026), U2 Total Knee System Femoral Offset Bushing Recall: Incorrect Implant Orientation Risk (March 19, 2026), and Grace Medical recalls Stapes Prosthesis due to incorrect labeling (April 3, 2026).

How to tell if you have this one

Check if your hip replacement stem has a serial number listed in the recall (e.g., 422796, 424450, 425346, 429552, 431199, 435657, 437425, 442745). The product is labeled as 'HIP-PATIENT SPECIFIC STEM LEFT' and includes specific model numbers (HBS-033-00xx-010101).

Brand
Conformis
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity
Z-1775-2019	Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT); HBS-033-0010-010101: Serial Numbers:423398, 424244, 424392, 425455, 425607, 425755, 426309, 427186, 428901, 430404,430766, 431394,431844, 434871, 436520, 438363, 438925, 439064, 439561, 440369, 441662, 441734; HBS-033-0011-010101: Serial Numbers:422796, 424450, 424510, 426034, 426118, 430150, 430534, 431142, 431502, 431581, 432030, 433555, 434136, 434439, 435282, 436108, 436212, 437452, 437657, 437745, 437968, 440603, 442816; HBS-033-0012-010101: Serial Numbers: 425346, 425608, 425866, 427702, 427754, 429459, 429844, 430053, 430087, 432011, 432363, 436792, 437653, 438516, 439063, 440253; HBS-033-0013-010101: Serial Numbers: 422797, 424647, 425456, 426297, 427360, 427898, 428372, 428957, 429014, 429921, 429937, 430338, 430613, 430962, 433445, 434149, 434451, 434635, 435118, 436125, 436230, 436333, 437073, 438024, 438112, 439641, 439929, 441028, 441030; HBS-033-0014-010101: Serial Numbers: 423231, 425276, 426069, 426382, 427480, 427752, 427883, 428820, 428900, 431315, 431333, 431977, 432543, 432953, 434612, 435649, 435883, 435910, 436122, 437322, 437863, 438631, 440445; HBS-033-0015-010101: Serial Numbers: 429552, 432936, 433085, 437373, 437681, 437925, 439272 HBS-033-0016-010101 425418, 428545, 431199, 435657, 436790, 437425, 437656, 442745; HBS-033-0016-010101: Serial Numbers:425418, 428545, 431199, 435657, 436790, 437425, 437656, 442745	128
Z-1776-2019	Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT); HBS-033-0010-020101: Serial Numbers: 425365, 425428, 425767, 425954, 426249, 426408, 426508, 426722, 426725, 428146, 428328, 429186, 429310, 429857, 430590, 431869, 432271, 432292, 432555, 432773, 433524, 434063, 436063, 436522, 438792, 439464, 439559, 441029; HBS-033-0011-020101: Serial Numbers: 423937, 424879, 425273, 425425, 425457, 425605, 425627, 426730, 427699, 427760, 427897, 428066, 428791, 428802, 429699, 429829, 429856, 429940, 430691, 431029, 432687, 434510, 435069, 435409, 435886, 435961, 436017, 436659, 437864, 437866, 438568, 439309, 439457, 439650, 441929; HBS-033-0012-020101: Serial Numbers:424288, 424377, 426081, 426298, 426581, 426608, 426873, 427353, 427759, 428504, 428744, 428814, 428940, 429787, 429854, 429928, 430045, 430344, 430780, 431025, 431032, 431443, 431813, 432098, 432925, 434265, 434704, 435120, 435483, 435790, 436682, 436891, 437036, 437050, 438471, 438511, 438570, 439453, 439471, 439738, 441009, 441527, 442347; HBS-033-0013-020101: Serial Numbers: 423539, 425277, 426121, 430033, 430129, 430461, 432012, 434291, 435938, 436951, 437614, 437654, 437776, 437932, 438157, 438304, 438384, 439822, 440273, 440446, 441053, 441714, 442149; HBS-033-0014-020101: Serial Numbers: 423852, 425345, 425968, 426897, 427830, 428294, 428697, 428836, 429416, 430028, 431541, 432156, 432399, 432421, 432440, 432524, 433245, 434239, 434884, 435146, 435366, 437208, 438079, 438485, 438916, 438991, 439849, 440604, 440673, 441492; HBS-033-0015-020101: Serial Numbers: 426179, 429192, 429828, 429855, 431489, 431512, 432017, 433642, 436330, 437089, 437495, 437651, 437714, 437906, 438105, 438296, 438739, 438784, 440265; HBS-033-0016-020101: Serial Numbers: 426119, 435562, 437516, 438708, 440704	183

Based on the official FDA remedy

What to do — step by step

Check Your Stem Serial Number
Look for the serial number on your hip replacement stem to see if it matches any of the listed numbers in the recall.
Contact Conformis
Reach out to Conformis directly to confirm if your stem is affected and get instructions for next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

Mar 29, 2019Firm started the recall
Jun 13, 2019FDA classified it Class II
Jun 19, 2019Published in FDA’s Enforcement Report
Apr 28, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Conformis recalls

Link to this recall

<a href="https://govinfonow.com/recall/68535-conformis-itotal-hip-replacement-system-recall-3mm-neck-head-length">Conformis iTotal Hip Replacement System Recall: 3mm Neck/Head Length Discrepancy Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1775-2019 (March 29, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1775-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.