The Recall Desk
HighFDA (Devices)·Z-0484-2022·Announced 2022-01-19

GLOBAL UNITE STD STEM orthopedic implant manufacturing defect recall

DePuy Orthopaedics is recalling GLOBAL UNITE STD STEM orthopedic implants due to undersized spigot bore diameter that may prevent proper removal during revision surgery, risking surgical delay and bone damage.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with a documented manufacturing defect that creates risk of surgical delay and bone damage during implant revision. No illnesses or injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 432 units of the GLOBAL UNITE STD STEM orthopedic implant (Part Number 110008100) distributed worldwide including the United States and 22 other countries.

The recalled units have an undersized spigot bore diameter, a manufacturing defect that prevents proper separation of the proximal body from the stem. This defect may require surgical delay and risks bone damage during revision surgery when the implant must be removed.

The defect affects 51 specific lot numbers (9793035 through 9887446). Healthcare providers and patients with this implant should review their implant's lot number and contact their surgeon or DePuy Orthopaedics to discuss options and next steps.

The recalled product

Product
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
432

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot # s 9793035
  • 9802134
  • 9802135
  • 9802136
  • 9802137
  • 9802138
  • 9802139
  • 9802140
  • 9802141
  • 9802142
  • 9802143
  • 9802144
  • 9802145
  • 9802146
  • 9802147
  • 9802148
  • 9802149
  • 9802150
  • 9802151
  • 9814515

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

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