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 D
FDA device recall Z-2087-2017 · posted 2017-04-24 · Terminated
Recall details
- Recalling firm
- Aesculap Implant Systems LLC
- Reason for recall
- 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.
- Action taken
- On April 7, 2017 8 Hospitals, 3 distributors and 11 sales reps were sent an Urgent Medical Device Recall Notification letter. Letters were sent UPS overnight. Customers were asked to immediately discontinue use and return the product to Aesculap, Inc.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEY
- Quantity affected
- Total of all burrs - 608 units
- Distribution
- US Nationwide distribution - CA, IL, NY, PA, TN, TX
- Date initiated
- 2017-03-28
- Date posted
- 2017-04-24
- Date terminated
- 2018-02-06
- Location
- Center Valley, PA
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