Recall Z-1870-2013 ยท FZY Hammer, Surgical
SpineFrontier, Inc.
S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.
| Date | Aug 1, 2013 (initiated Apr 25, 2013) |
| Status | Terminated |
| Reason | Malfunction of slap hammer. |
| Root cause | Device Design |
| Action | The firm, SpineFrontier, sent an advisory notice entitled "URGENT April 25, 2013 S-LIFT Slap Hammer Removal" dated April 25, 2013 via email to its customers. The notice described the product, problem and action to be taken. The notice requested the removal of all distributed SLIFT Slap Hammer with listed lot number. The customers were instructed to complete and return the URGENT S-LIFT Slap Hammer Removal ACKNOWLEDGEMENT FORM via fax to: SpineFrontier, Inc., 978-232-3991 or email to customerservice@spinefrontier.com. Please feel free to contact SpineFrontier at 978-232-3990 with any questi |
| Quantity | 3 |
| Distribution | US distributions to states of: KS and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.