Recall Z-3207-2011 ยท NKB Thoracolumbosacral Pedicle Screw System
Synthes USA (HQ), Inc.
Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
| Date | Sep 15, 2011 (initiated Mar 11, 2011) |
| Status | Terminated |
| Reason | Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolongation of OR time. |
| Root cause | Labeling Change Control |
| Action | The firm initiated this action on March 11, 2011 by issuing an Urgent: Medical Device Labeling Correction letter to all consignees. The letter identified the affected product and stated the reason for the correction. It also instructed the consignee to review and attach the supplementary technique page to any MATRIX Spine System Technique Guides that they may have had in their facility. Customers are to complete the Verification Section of the letter and return it to the firm via mail, fax, or e-mail. If customers have questions, they can call 610-719-5063 or their Synthes Spine Sales Cons |
| Distribution | Nationwide Distribution -- AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI. |
| FDA record | Open on fda.gov |