Reported Aug 1, 2018 · Terminated

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

Implantcast GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: IMPLANTCAST GMBH · Luneburger Schanze 26 · Buxtehude, N/A · N/A

Is this the product you have?

4 of 4 products

Products covered by this recall
#Product as published
1REF number 02423839 Size 42/44 mm
2REF number 02424244 Size 44/48 mm
3REF number 02424448 Size 46/52 mm
4REF number 02424652
Lot codes and dates

4 of 4 products

Products covered by this recall
#Product as published
1Size 38/39 mm REF number 02423839 Batch 150201G, 1504298, 1504299, 150429C, 150429L
2Size 42/44 mm REF number 02424244 Batch 1702188, 15042AF, 15042A7, 15042A6, 15042A5
3Size 44/48 mm REF number 02424448 Batch 1702189, 1637108, 16141C1
4Size 46/52 mm REF number 02424652 Batch 1637109, 16141C2.
Amount recalled
304, 3 in US

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 1, 2020 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.