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Terminated

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

FDA Recall Z-3020-2020 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodePHX
Date Initiated2020-08-24
Date Terminated2023-05-01
Product Quantity149 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.

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