—#190913

Product

GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610

FDA product code: PHX — Shoulder Prosthesis, Reverse Configuration
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K101996, K170748
Affected lot / code info: Lot #: 9792595, 9793039, 9802121, 9813506. 9818509, 9830922, 9840359,9858603 GTIN: 10603295004011

Why it was recalled

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Root cause (FDA determination)

Equipment maintenance

Action the firm took

DePuy notified US hospital / government consignees on 12/7/21 letter Urgent Medical Device Recall (Removal) via the sales consult and product will be removed/notice delivered by hand or if not able to enter facility the form will be emailed and returns will be arranged. US sales/distributor offices will be notified via email. Affiliates outside of the US affiliates will be notified via the electronic system and recall activities will be carried out per local regulations. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the select lots and quarantine the product. 2. Return the subject product(s) using the normal returns process. Work with your sales consultant to return subject product(s). To receive replacement product(s) or reimbursement, customers must return the products subject to this removal. 3. Review, complete all fields, sign, and return the attached business response form (BRF) on the last page of this letter to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this Removal Letter. Please include in the email subject: FA 2044436 - 2021 GLOBAL UNITE Stems with undersized Spigot Bore Diameter. 4. Forward this Removal Letter to any personnel in your facility who need to be informed. 5. If any of the product(s) subject to this Removal have been forwarded to another facility, contact that facility and provide a copy of this Removal Letter to the relevant personnel. 6. Post a copy of this Removal Letter in a visible area for awareness of this Removal. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

Timeline

Recall initiated: 2021-12-07
Terminated: 2024-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190913. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.