Recall Z-0718-2014 ยท HTW Bit, Drill
The Anspach Effort, Inc.
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
| Date | Jan 11, 2014 (initiated Sep 9, 2011) |
| Status | Terminated |
| Reason | Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier. |
| Root cause | Packaging change control |
| Action | Recalling firm notified direct accounts by letter on 09/09/11. Direct accounts were instructed to screen their inventory immediately for product packaged with the Tyvek Pouch/Tube Configuration, complete the reply form, and return the products to the firm. |
| Quantity | 1,805,022 cutting burs and 55,026 irrigation clips |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jordan, Germany, Brazil, Mexico, Israel, Cameroon, Switzerland, South Africa, Greece, Finland, Taiwan, H |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.