Aesculap Implant Systems LLC: Medical Device Recall in 2012 - (Recall #: Z-1934-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 7, 2012

Date Posted: July 11, 2012

Recall Number: Z-1934-2012

Event ID: 62240

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.

Status: Terminated

Product Quantity: 15

Code Information:

All distributed lot numbers and serial numbers

Distribution Pattern:

Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .

Voluntary or Mandated:

Voluntary: Firm initiated