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

PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer

FDA Recall Z-0961-2009 · Posted 2009-02-03

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeKWS
Date Initiated2008-11-21
Date Terminated2012-11-27
Product Quantity51 units

Reason for Recall

The product was breaking during use.

Firm Action

All affected Smith & Nephew International Distributors were notified via email on 11/21/2008. They were instructed to immediately notify their accounts concerning the recall. Contact Smith & Nephew Inc at 901-399-6771 for assistance.

Root Cause

Other

Distribution Pattern

Germany, France, Italy Austria, Switzerland, Belgium, United Kingdom, Greece, Australia, South Africa, Spain, and Cypress

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081016SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEMSmith & Nephew, Inc. · 2008-09-05

Official Source

View FDA Recall →

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

↑