NuOss XC Sinus recall
NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height)…
Why was NuOss XC Sinus recalled?
During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot BMCXU11P1. BMCXU11H3 Lot BMCXU11P1, BMCXU12P1
- Product
- NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height)…
- Recalling firm
- Collagen Matrix Inc
- Quantity
- 347 units
- Distribution
- US Distribution to state of: MA.
- Recall date
- March 23, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)