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

DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.

FDA Recall Z-1319-2015 · Posted 2015-03-25

Recalling FirmIn2Bones, SAS
Recall StatusTerminated
Product CodeHWC
Date Initiated2015-03-09
Date Terminated2016-05-19
Product Quantity15 units

Reason for Recall

Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

Firm Action

The firm notified their sole consignee in the US by email on 03/09/2015 requesting the return of the product, and to notify his consignee(s) to quarantine the unused product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed in the state of TN.

Official Source

View FDA Recall →

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

↑