Z-1569-2025Class II

restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular...

Name: Z-1569-2025 restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular...
Creator: Conformis Inc.
Published: 2025-03-25
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2025-03-25 / Open, Classified / root cause: labeling and UDI

FDA source

Conformis Inc. began a recall of restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System on 2025-03-25. FDA classified it as Class II and gives the reason as "The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1569-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-25
Posted: 2025-04-15
Recalling firm: ConforMIS, Inc.
Product: restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On about 03/25/2025, Conformis notified consignees via email with letter titled "URGENT: MEDICAL DEVICE RECALL." Consignees were instructed to examine inventory, quarantine any affected units on hand, and make arrangements to return the product. Additionally, consignees were asked to complete and return the response portion of the letter.
Quantity in commerce: 16
Distribution: US Nationwide distribution in the states of CA, FL, NV, TN.
Product codes and lots: Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1569-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1569-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15

Product code LPH

K202484Class IICordera Hip SystemConformis, Inc. / cleared 2020-09-24

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)