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

CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE Orthopedic

FDA Recall Z-2605-2014 · Posted 2014-09-08

Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2014-07-30
Date Terminated2018-06-15
Product Quantity66 units

Reason for Recall

Plates manufactured from an incorrect raw material.

Firm Action

Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the product(s) on hand and return by fax to 901-867-7401. Customers with questions were instructed to call 901-290-5662. For questions regarding this recall call 800-238-7117.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113014CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWSWrightmedicaltechnologyinc · 2012-01-31K080295CHARLOTTE CLAW 3.5Wrightmedicaltechnologyinc · 2008-02-27

Official Source

View FDA Recall →

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

↑