GP161R recall: Particulate Matter
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3…
Why was GP161R recalled?
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
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?
Model numbers COARSE: GP161R ; GP162R ; GP163R ; GP164R ; GP165R ; GP166R ; GP167R ; GP168R ; GP169R ; GP170R ; Model numbers X-Course: GP173R ; GP174R ; GP175R ; GP176R ; GP177R ; GP328R ; GP329R ; GP330R ;
- Product
- GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3…
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- Total of all burrs - 608 units
- Distribution
- US Nationwide distribution - CA, IL, NY, PA, TN, TX
- Recall date
- May 24, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)