—#137818

Product

ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K103835
Affected lot / code info: Catalog #5901-S-4818, Lot MAC7C14.

Why it was recalled

A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.

Root cause (FDA determination)

Process control

Action the firm took

Stryker Orthopaedics notified their branches/agencies via email on 5/12/2015 and sent notification letters and product accountability forms to hospital risk management/branches on 7/15/2015 and 7/16/2015

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2015-05-12
Posted by FDA: 2015-08-10
Terminated: 2016-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137818. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.