Z-3207-2011

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

Name: Z-3207-2011 Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior...
Creator: Synthes USA (HQ), Inc.
Published: 2011-03-11
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2011-03-11 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA (HQ), Inc. began a recall of 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... on 2011-03-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3207-2011
Status: Terminated
Initiated: 2011-03-11
Posted: 2011-09-15
Terminated: 2014-12-18
Recalling firm: Synthes GmbH
Product: 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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: labeling and UDI
FDA 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 Consultant.
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.
Product codes and lots: All lots

Product code NKB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)