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GLOBAL UNITE recallZ-0484-2022 · DePuy Orthopaedics, Inc. · initiated Dec 7, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Equipment maintenance

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-0484-2022
Status
Terminated
Initiated by the company
Dec 7, 2021
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
432 units
Product code
PHX
FDA submissions
K170748, K101996
Distribution
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.

Product description

GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

64 devices cleared under K170748, K101996 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89240).

Sources and updates

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