Recall Z-0161-2012 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Synthes USA (HQ), Inc.
Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL 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 interior of the
| Date | Nov 4, 2011 (initiated Sep 23, 2011) |
| Status | Terminated |
| Reason | LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All |
| Root cause | Error in labeling |
| Action | SYNTHES sent an URGENT MEDICAL DEVICE LABELING CORRECTION letter dated September 23, 2011, to all affected customers. The labeling has been revised. Updated information packets have been sent to all accounts which included the final labeling and communications to accounts and sales force. Customers were instructed to review the updated supplemental labeling provided in the package Customers were instructed to attach the supplementary technique page to an T-PAL Spacer Brochure that may be in their facility. They can access an electronic version of the Brochure by accesssng Product Literatu |
| Quantity | N/A - Labeling Correction |
| Distribution | Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, HI, KS, KY, LA, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. and Puerto Rico and Washington, D.C; Internationally to Canada and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100089 | SYNTHES T-PAL SPACER Synthes Spine, May 13, 2010 |