Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw

FDA device recall Z-3207-2011 · posted 2011-09-15 · Terminated

Recall details

Recalling firm

Synthes USA (HQ), Inc.

Reason for recall

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.

Action taken

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 Consultant.

Root cause

Labeling Change Control

Status

Terminated

Product code

NKB

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.

Date initiated

2011-03-11

Date posted

2011-09-15

Date terminated

2014-12-18

Location

West Chester, PA

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