FDA Medical Device Recalls (openFDA)
IMPLANTCAST GMBH: 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
- Recall number
- Z-2517-2018
- 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
- Status
- Terminated
- Initiated
- 2017-12-28
- Posted
- not on file
- Terminated
- 2020-09-01
- Reason
- Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
- 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
- 304, 3 in US
- Distribution
- Distribution in Europe and US states of Texas, Rhode Island and Georgia.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 3012523063
- Firm city
- Buxtehude
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28