Z-1934-2012Class II

S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the...

Name: Z-1934-2012 S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the...
Creator: Aesculap Implant Systems LLC
Published: 2012-03-07
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2012-03-07 / Terminated / root cause: design

FDA source

Aesculap Implant Systems LLC began a recall of S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision... on 2012-03-07. FDA classified it as Class II and gives the reason as "Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1934-2012
Classification: Class II
Status: Terminated
Initiated: 2012-03-07
Posted: 2012-07-03
Terminated: 2012-08-08
Recalling firm: Aesculap Inc
Product: S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Product code: HWW Countersink
Reason for recall: Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm initiated their recall of this product by issuing an "Important Product Removal Notification" letter to all consignees dated March 7, 2012. The letter described the problem, advised them not to use the product, and instructed consignees to return the instruments to the recalling firm with the attached Distribution Inventory Sheet. Customer Service may be contacted if questions at 1-866-229-3002.
Quantity in commerce: 15
Distribution: Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
Product codes and lots: All distributed lot numbers and serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1934-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1934-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-03

Product code HWW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)