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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- IMPLANTCAST GMBH
- Reason for Recall:
- Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
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:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2517-2018
Related Recalls
A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.