Anjon Bremer Molded Crown. bone fixation fastener for recall
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation…
Why was Anjon Bremer Molded Crown. bone fixation fastener for recalled?
High rate of galling of one threaded component.
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?
REF number 100048 Lot # 170240, US customer Lot # 170162, 170163, 70164,170165, 170229, 170240, 170247, 170260 and SM 42048. International customers.
- Product
- Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation…
- Recalling firm
- Anjon Holdings
- Quantity
- 249 devices
- Distribution
- Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.
- Recall date
- August 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)