Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.

FDA Recall Z-1934-2012 · Posted 2012-07-03

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeHWW
Date Initiated2012-03-07
Date Terminated2012-08-08
Product Quantity15

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑