Agency classClass IIOur severity:High FDA (Devices)·Z-0488-2022·Announced 2022-01-19

Orthopaedic Stem Implants Recalled for Undersized Bore Manufacturing Defect

DePuy Orthopaedics is recalling approximately 870 GLOBAL UNITE STD STEM implants worldwide because an undersized spigot bore may prevent proper separation, causing potential 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: This is an FDA Class II medical device with a manufacturing defect that prevents proper device separation, potentially causing surgical delay or bone damage. No injuries or hospitalizations have been reported, fitting the criterion for a high-severity 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 12 (Product Code: 110012100) orthopaedic implants. The devices are affected by a manufacturing defect: the spigot bore diameter is undersized, which may prevent proper separation of the proximal body from the stem without surgical delay and/or bone damage.

The recall involves approximately 870 units distributed worldwide. Distribution includes 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 the United Kingdom. The GTIN is 10603295004127.

Patients and healthcare providers who have received affected implants should contact DePuy Orthopaedics to discuss this recall. Physicians should evaluate patients on an individual basis to determine the appropriate management approach for their specific situation.

The recalled product

Product: GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Orthopaedic Implant
Hazard: manufacturing-defect
surgical-delay
bone-damage
Affected units: 870

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 #: 9793650
9793651
9793652
9802212
9802213
9802214
9802215
9802216
9802217
9802218
9802219
9802220
9802221
9802222
9802223
9802224
9802225
9802226
9802227
9802228

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 →

Same manufacturer · DePuy Orthopaedics, Inc.

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