The Recall Desk
HighFDA (Devices)·Z-0489-2022·Announced 2022-01-19

Hip Stem Device Recalled Due to Undersized Bore Diameter Risk

DePuy Orthopaedics recalls the GLOBAL UNITE STD STEM SZ 14 hip stem in 451 units worldwide due to undersized spigot bore diameter. The defect may prevent proper separation of the stem during surgery without surgical delay or 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: This is a Class II medical device recall involving a risk-of-harm product with a real structural defect that could cause surgical complications. However, no injuries or illnesses have been reported, meeting the rubric criterion for Score 3.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling the GLOBAL UNITE STD STEM SZ 14 hip stem device (Product Code 110014100) due to a manufacturing defect in the spigot bore diameter. The recalled units have an undersized bore diameter, which is a critical structural dimension of the implant.

The defect may prevent the proximal body from separating from the stem during implantation or revision procedures without surgical delay and/or bone damage. This creates a risk of intraoperative complications for patients receiving the affected implants.

The recall affects 451 units distributed worldwide, including the United States and 22 countries across Europe, Asia, Africa, and Oceania. Affected lot numbers include 9792322, 9792323, 9793656, 9793942, 9793943, and 49 additional lot codes (refer to FDA database for the complete list).

Patients who have received implants from the affected lots should contact their healthcare provider immediately. Healthcare providers should cease use of the affected implants and contact DePuy Orthopaedics for replacement guidance and options.

The recalled product

Product
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant / Hip Stem
Hazard
  • spigot-bore-defect
  • separation-failure
  • bone-damage

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#: 9792322
  • 9792323
  • 9793656
  • 9793942
  • 9793943
  • 9802283
  • 9802284
  • 9802285
  • 9802286
  • 9802287
  • 9802288
  • 9802289
  • 9802290
  • 9802291
  • 9802292
  • 9802293
  • 9802294
  • 9802295
  • 9802296
  • 9802297

Distribution

Distributed nationwide across the United States.

Related recalls

Same category