SPEED 15X12X12mm Continuous Compression Implant recall
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Why was SPEED 15X12X12mm Continuous Compression Implant recalled?
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
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 (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
- Product
- SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 94 US; 30 OUS
- Distribution
- US Nationwide distribution.
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)