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.
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 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.
- Hazard
- manufacturing-defect
- surgical-delay
- 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 #: 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.
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