Implantcast Recalls Hip Implant Inserts Due to Retaining Ring Mounting Risk
Implantcast GmbH is recalling specific 2M insert 15degree orthopedic hip implant components because the retaining ring may be incorrectly mounted.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (incorrectly mounted retaining ring) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Implantcast GmbH is recalling specific 2M insert 15degree components used in MUTARS RS cup and LUMiC TiN orthopedic hip implants. The recall involves 304 units, with 3 units distributed in the United States. The affected products are distributed in Europe and in the US states of Texas, Rhode Island, and Georgia.
The recall is being issued because there is a possibility that the retaining ring in the 2M inlay 15degree is incorrectly mounted. The affected reference numbers and batch numbers are: Size 38/39 mm (REF 02423839, Batches 150201G, 1504298, 1504299, 150429C, 150429L); Size 42/44 mm (REF 02424244, Batches 1702188, 15042AF, 15042A7, 15042A6, 15042A5); Size 44/48 mm (REF 02424448, Batches 1702189, 1637108, 16141C1); and Size 46/52 mm (REF 02424652, Batches 1637109, 16141C2).
Healthcare providers and patients should contact Implantcast GmbH for further information regarding the recall and potential replacement or repair options.
The recalled product
- 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
- Manufacturer
- IMPLANTCAST GMBH
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
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