Z-0396-2014Class II

Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical...

Name: Z-0396-2014 Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical...
Creator: Synthes USA HQ, Inc.
Published: 2012-09-07
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2012-09-07 / Terminated

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior... on 2012-09-07. FDA classified it as Class II and gives the reason as "This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0396-2014
Classification: Class II
Status: Terminated
Initiated: 2012-09-07
Posted: 2013-11-26
Terminated: 2015-12-18
Recalling firm: Synthes GmbH
Product: Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.
FDA root cause: Use error
Action: Synthes sent an Urgent: Medical Device Product Removal letter on September 7, 2012, to all affected consignees. Consignees were requested to immediately cease using the product, examine their inventory and remove the parts from inventory. If they had the parts, they were further instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the verification section at the end of the letter and return the verification form. If they did not have the parts, they were requested to complete the verification section at the end of the letter and return the verification form. Consignees with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 745
Distribution: Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0396-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0395-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26
Z-0396-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

Product code NKB

K113044Class IISynthes MirsSynthes Spine / cleared 2011-12-21

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)