S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occ

FDA device recall Z-1934-2012 · posted 2012-07-03 · Terminated

Recall details

Recalling firm

Aesculap Implant Systems LLC

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

HWW

Quantity affected

15

Distribution

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

Date initiated

2012-03-07

Date posted

2012-07-03

Date terminated

2012-08-08

Location

Center Valley, PA