Recall Z-2282-2013 ยท LXH Orthopedic Manual Surgical Instrument
Synthes USA HQ, Inc.
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in
| Date | Sep 26, 2013 (initiated Jan 11, 2013) |
| Status | Terminated |
| Reason | This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use. |
| Root cause | Device Design |
| Action | SYNTHES sent an Urgent Notice Medical Device Recall letter dated January 11, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees examine their inventory, remove the recalled product from use and return them to Synthes. Customers were also instructed to completed the attached Verification Section at the end of the letter indicating whether or not they had any of the affected product and the number of devices found. Customers with questions were instructed to call 610-719-5450 or email F |
| Quantity | 27 |
| Distribution | Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.