Z-2517-2018Class II

2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm...

Name: Z-2517-2018 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm...
Creator: Implantcast Gmbh
Published: 2017-12-28
License: https://open.fda.gov/license/

implantcast GmbH / initiated 2017-12-28 / Terminated / root cause: manufacturing process

FDA source

IMPLANTCAST GMBH began a recall of 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number... on 2017-12-28. FDA classified it as Class II and gives the reason as "Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2517-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-28
Posted: 2018-07-20
Terminated: 2020-09-01
Recalling firm: implantcast GmbH
Product: 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Implantcast sent customers an Urgent Product Safety Information / Product Recall letter on December 28, 2017. The letter recommends that physicians follow their patients by radiological exam. There is a return form for the hospital or physician to confirm receipt of the letter.
Quantity in commerce: 304, 3 in US
Distribution: Distribution in Europe and US states of Texas, Rhode Island and Georgia.
Product codes and lots: Article/Batch numbers: Size 38/39 mm REF number 02423839 Batch 150201G, 1504298, 1504299, 150429C, 150429L; Size 42/44 mm REF number 02424244 Batch 1702188, 15042AF, 15042A7, 15042A6, 15042A5; Size 44/48 mm REF number 02424448 Batch 1702189, 1637108, 16141C1; Size 46/52 mm REF number 02424652 Batch 1637109, 16141C2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2517-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2517-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-20

Product code LZO

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)