The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0486-2022·Announced 2022-01-19

Hip stem implants recalled due to undersized bore defect

DePuy Orthopaedics is recalling 781 hip stem implants that may have an undersized spigot bore diameter, potentially preventing surgical removal without additional surgical delay or bone damage.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 recall for a hip stem implant with a manufacturing defect that may require additional surgical intervention and could cause bone damage during device removal. No illnesses, injuries, or deaths are reported in the source, but the risk-of-harm criterion applies given the potential for surgical complications and bone damage.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 781 units of GLOBAL UNITE STD STEM SZ 10 hip stem implants (Part Number: 110010100) due to a manufacturing defect. Some units may have an undersized spigot bore diameter, which could prevent proper surgical separation of the proximal body from the stem.

The affected devices were distributed worldwide, including throughout the United States and to Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, and the United Kingdom. A complete list of affected lot numbers is available from the FDA.

If the defect is discovered during implant removal surgery, the undersized bore diameter may prevent separation of the stem without additional surgical delay and/or risk of bone damage. Orthopedic surgeons and hospitals with affected devices should review patient records and consult with DePuy Orthopaedics regarding management of implanted units.

Patients who have received one of these implants should contact their orthopedic surgeon or healthcare provider if they have concerns, particularly if revision or removal surgery becomes necessary.

The recalled product

Product
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic / Hip Implant
Hazard
Affected units
781

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 #: 9793653
  • 9802160
  • 9802161
  • 9802162
  • 9802163
  • 9802164
  • 9802165
  • 9802166
  • 9802167
  • 9802168
  • 9802169
  • 9802170
  • 9802171
  • 9802172
  • 9802173
  • 9802174
  • 9802175
  • 9802176
  • 9802177
  • 9802178

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 →

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