Recall Z-0411-2014 ยท HXX Screwdriver
Ebi, Llc
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system.
| Date | Nov 27, 2013 (initiated Sep 24, 2013) |
| Status | Terminated |
| Reason | Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case. |
| Root cause | Nonconforming Material/Component |
| Action | Biomet sent an Urgent Medical Device Recall Letters/Fax Back Response Form dated September 24, 2013, via Fed Ex. The customer is asked to examine their inventory and return the recalled product following the attached instructions. The Fax Back Response Form should be completed and returned to 973-887-1347 prior to the return of the product. Any questions please call (973) 299-9300 x 2162. |
| Quantity | 2 units |
| Distribution | US Distribution to CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.