Recall Z-0931-2009 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Synthes Spine
Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autogra
| Date | Jan 30, 2009 (initiated Nov 20, 2008) |
| Status | Terminated |
| Reason | screwdriver tip may break off and lodge in the screw head |
| Root cause | Device Design |
| Action | The recalling firm emailed all Spine Sales Consultants on 11/20/08. They were instructed to immediately examine their stock and discuss appropriate technique with surgeon users. In addition, a Medical Device Correction letter dated 11/19/08 was issued via USPS certified mail to the medical facilities. This initial letter stated the issue and requested the users take the following actions: discard all SynFix Technique Guides and replace with the updated literature contained in the mailing packet with the letter, and is identified by code J7022-E (Rev. E); to ensure receipt and understanding of |
| Quantity | 381 units |
| Distribution | Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA ,SC, TN, TX, UT, VA, WA, and WI, and countries of Canada and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072253 | SYNFIX-LR SPACER Synthes Spine Co.Lp, Oct 12, 2007 |