Z-1776-2019Class II

Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)

Name: Z-1776-2019 Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Creator: Conformis, Inc.
Published: 2019-03-29
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2019-03-29 / Terminated / root cause: design

FDA source

Conformis, Inc. began a recall of Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT) on 2019-03-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1776-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-29
Posted: 2019-06-13
Terminated: 2020-04-28
Recalling firm: ConforMIS, Inc.
Product: Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Conformis issued on 29 Mar 2019 via e-mails to surgeons with upcoming surgeries the following: 1. For surgeons who have already performed the surgeries (i.e. for patients whose implant surgeries were completed between July 31st, 2018 and March 27th, 2019), a letter sent letter advising them of the issue. Confirmation of receipt will be requested. 2. For surgeons who have not performed the surgeries, but have approved the iView surgical plan on or before March 27, 2019, and Conformis has been notified of confirmed surgery dates or Conformis has provided commitment dates on or before May 17th 2019, a. They will be provided with a marked-up iView surgical plan that provides the true dimensions of the manufactured implant and asked to choose to (i) continue with surgery, (ii) postpone surgery to allow Conformis to manufacture a new implant with a head/neck length matching the original approved iView or (iii) cancel the order. b. Should the physician choose to proceed with the surgery using the manufactured implant with the 3 mm discrepancy, it will be shipped to them after receiving their written approval provided that the surgery is scheduled on or before May 17, 2019. c. Should the physician choose to postpone surgery, a new implant will be manufactured to match the approved iView and provided to the surgeon
Quantity in commerce: 183
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1776-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1775-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-13
Z-1776-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-13

Product code LPH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)