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Recall Observatory FDA recall evidence

Device 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

Z-2517-2018

December 28, 2017

Class II

Product summary

Firm
IMPLANTCAST GMBH
Event
Event 80498
Status
Terminated
Classification
Class II
Quantity
304, 3 in US
Official record key
device-enforcement:Z-2517-2018

Official wording

Reason: Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.

Code information: 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.

Distribution pattern: Distribution in Europe and US states of Texas, Rhode Island and Georgia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.