The Recall Desk
HighFDA (Devices)·Z-0483-2022·Announced 2022-01-19

Hip Stem Component Recalled Due to Undersized Bore Diameter

DePuy is recalling GLOBAL UNITE STD STEM SZ 6 orthopedic stems due to undersized spigot bore that may prevent safe removal during revision surgery, risking surgical delays 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 recall of an orthopedic implant with a manufacturing defect affecting structural integrity and removal capability. The defect creates documented risk of surgical delay and bone damage during revision procedures, qualifying as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling the GLOBAL UNITE STD STEM SZ 6 orthopedic stem component (Part Number 11000610). The affected units were distributed worldwide, including throughout the United States and internationally 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 United Kingdom.

The recalled stems may have an undersized spigot bore diameter. This manufacturing defect may prevent separation of the proximal body from the stem without surgical delay and/or bone damage. If revision surgery is needed and the stem cannot be properly separated, surgeons may encounter extended operative time and inadvertent bone damage during removal.

Patients who have received this implant should consult their surgeon to determine if their device is affected. The recalled lot numbers are: 9792595, 9793039, 9802121, 9813506, 9818509, 9830922, 9840359, and 9858603. Healthcare providers should contact DePuy Orthopaedics for guidance on management of affected devices.

No injuries or illnesses have been reported in association with this defect.

The recalled product

Product
GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Joint Prosthesis
Hazard
  • bore-defect
  • removal-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 (7)

  • Lot #: 9792595
  • 9793039
  • 9802121
  • 9813506. 9818509
  • 9830922
  • 9840359
  • 9858603 GTIN: 10603295004011

Distribution

Distributed nationwide across the United States.

Related recalls

Same category