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

Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.

FDA Recall Z-1629-2014 · Posted 2014-05-16

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2013-12-03
Date Terminated2016-04-18
Product Quantity150

Reason for Recall

The Irrigation Clips were assembled with the incorrect (smaller) clips.

Firm Action

The firm, Anspach, sent an URGENT: Medical Device Removal letter dated December 3, 2013 to its customer. The letter described the product, problem and actions to be taken. Should you have any queries, please do not hesitate to contact Aspach Customer Support at (800) 327-6887.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US Nationwide Distribution in the state of Mississippi.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030576ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP IIThe Anspach Effort, Inc. · 2003-05-21

Official Source

View FDA Recall →

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

↑