The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0487-2022·Announced 2022-01-19

Orthopaedic Implant Stems Recalled for Undersized Spigot Bore Defect

DePuy Orthopaedics is recalling GLOBAL UNITE REV STEM SZ 10 implants because the spigot bore may be undersized, preventing proper separation of components during revision surgery and potentially causing 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 an FDA Class II recall with a structural defect (undersized spigot bore) that creates a genuine risk of bone damage during revision surgery. No actual injuries have been reported in the source, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling GLOBAL UNITE REV STEM SZ 10 orthopaedic implant stems (Product Code: 110010600) due to a manufacturing defect affecting the spigot bore.

The affected stems may have an undersized spigot bore diameter. This defect can prevent proper separation of the proximal body from the stem, potentially resulting in surgical delay and bone damage during revision surgery or device removal.

The recall affects 3 units with lot number 9809673 (GTIN: 10603295004097). Distribution was worldwide, including the United States and the following countries: 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 product

Product
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopaedic 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 #: 9809673 GTIN: 10603295004097

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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