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

EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory P/N 469060.

FDA Recall Z-0917-05 · Posted 2005-06-22

Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeHXI
Date Initiated2005-03-16
Date Terminated2006-06-30
Product Quantity167 units

Reason for Recall

The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.

Firm Action

The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005.

Root Cause

Other

Distribution Pattern

These devices are distributed nationwide to sales representatives who provide the product directly to the hospital/physician at the time of the surgery. The product was also distributed to Italy and Spain. There are no government accounts.

Official Source

View FDA Recall →

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

↑