The Recall Desk
HighFDA (Devices)·Z-0490-2022·Announced 2022-01-19

Hip prosthetic stem undersized bore complicates removal surgery

DePuy Orthopaedics' GLOBAL UNITE STD STEM prosthetics may have undersized spigot bores, complicating removal during revision surgery. Affected patients may experience surgical delays 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 an FDA Class II device recall with a structural manufacturing defect that creates significant risk of surgical complications and bone damage during revision surgery. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

DePuy Orthopaedics is recalling the GLOBAL UNITE STD STEM SZ 16 hip prosthetic stems due to a manufacturing defect: the spigot bore diameter may be undersized.

This defect prevents the proximal body from separating safely from the stem during revision surgery. Surgeons may face delays and patients may sustain bone damage during removal procedures.

Approximately 140 units have been distributed worldwide, including throughout the United States and 22 other countries including Canada, Europe, and other regions. Affected lot numbers are: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, and 9887452.

Patients with GLOBAL UNITE STD STEM implants should contact their surgeon or healthcare provider to determine if their implant is from an affected lot. Do not attempt removal without consulting your surgeon.

The recalled product

Product
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic / Hip Prosthetics
Hazard
  • structural-defect
  • removal-complication
  • 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 #: 9793946
  • 9793947
  • 9802315
  • 9802316
  • 9802317
  • 9802318
  • 9802320
  • 9813856
  • 9814516
  • 9824502
  • 9824503
  • 9824505
  • 9834401
  • 9834402
  • 9836078
  • 9841198
  • 9880972
  • 9886688
  • 9887451
  • 9887452 GTIN: 10603295004189

Distribution

Distributed nationwide across the United States.

Related recalls

Same category