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U.S. Department of Health and Human Services

Class 2 Device Recall GLOBAL UNITE STD STEM

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 Class 2 Device Recall GLOBAL UNITE STD STEMsee related information
Date Initiated by FirmDecember 07, 2021
Create DateJanuary 11, 2022
Recall Status1 Terminated 3 on May 17, 2024
Recall NumberZ-0484-2022
Recall Event ID 89240
510(K)NumberK101996 K170748 
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
ProductGLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
Code Information Lot # s 9793035, 9802134, 9802135, 9802136, 9802137, 9802138, 9802139, 9802140, 9802141, 9802142, 9802143, 9802144, 9802145, 9802146, 9802147, 9802148, 9802149, 9802150, 9802151, 9814515, 9817165, 9817166, 9817167, 9817168, 9817633, 9818331, 9824332, 9824334, 9824335, 9824336, 9824337, 9824338, 9824339, 9824340, 9824341, 9824342, 9824343, 9824344, 9824345, 9824346, 9824347, 9832804, 9851705, 9851706, 9851707, 9851708, 9862057, 9864147, 9874672, 9874674, 9874675, 9874676, 9874678, 9874682, 9874683, 9874686, 9874688, 9887446 GTIN: 10603295004042
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactSAME
574-267-8143
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Equipment maintenance
ActionDePuy 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.
Quantity in Commerce432 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PHX
510(K)s with Product Code = PHX
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