TRIDENTII HEMI CLUSTER54E- Indicated for use in primary recall
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
Why was TRIDENTII HEMI CLUSTER54E- Indicated for use in primary recalled?
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI:(01)07613327380880(17)290313(10) Lot Number: 15293151 15293153 15293152 15432252 15432254 15432451 15432351 15432251 15432253 16265752
- Product
- TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 225 units
- Distribution
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- Recall date
- May 1, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)