The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0485-2022·Announced 2022-01-19

DePuy Joint Stem May Have Undersized Bore, Complicating Surgical Removal

DePuy Orthopaedics has recalled 3 units of GLOBAL UNITE REV STEM SZ 8 due to an undersized spigot bore. Separation of the implant components may not be possible without surgical delay and/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: This is a structural manufacturing defect in a medical device that may cause complications (bone damage or surgical delay) during revision surgery, but no injuries have been reported. The FDA classified it as Class II. It meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 3 units of GLOBAL UNITE REV STEM SZ 8 (Part Number 110008600, Lot #9887449). This is a stemmed implant used in orthopedic joint reconstruction.

The recalled units may have an undersized spigot bore diameter. The spigot bore connects the proximal body to the stem. An undersized bore may make it impossible to separate these components during revision surgery without causing surgical delay and/or bone damage.

The product was distributed worldwide to patients in the United States and 22 other countries.

Patients with this implant should contact their orthopedic surgeon, particularly if revision surgery may be needed. Surgeons should be aware of this manufacturing defect when performing revision or removal procedures.

The recalled product

Product
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
3

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 (1)

  • Lot #: 9887449 GTIN:10603295004059

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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