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

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

FDA Recall Z-3019-2020 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodePHX
Date Initiated2020-08-24
Date Terminated2023-05-01
Product Quantity125 devices

Reason for Recall

Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.

Firm Action

On 8/24/2020 the firm provided a letter to their consignees with the following instructions: In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of this product. " Extend this information to your accounts that may have this product in their possesrion. " Identify and quarantine any of the subject devices in your inventory (including loaer kits). " Complete and return the attached Recall Inventory Response Form to Exactech via email a [email protected].

Root Cause

Labeling Change Control

Distribution Pattern

Domestic Distribution: KS, CA, AR, NY, OH, IL, WI, AZ, LA, KY, VA, IN, TX, HI, MN, FL, TN, GA, ID, ME, CO, WA, SC. International Distribution: Austria, Australia, Germany, France, Spain, Italy, Japan, United Kingdom, Luxembourg, Netherlands, South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063569EQUINOXE REVERSE SHOULDER SYSTEMExactech, Inc. · 2007-02-23

Official Source

View FDA Recall →

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

↑