GLOBAL UNITE STD STEM orthopedic implant manufacturing defect recall
DePuy Orthopaedics is recalling GLOBAL UNITE STD STEM orthopedic implants due to undersized spigot bore diameter that may prevent proper removal during revision surgery, risking surgical delay and 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: FDA Class II medical device recall with a documented manufacturing defect that creates risk of surgical delay and bone damage during implant revision. No illnesses or injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 432 units of the GLOBAL UNITE STD STEM orthopedic implant (Part Number 110008100) distributed worldwide including the United States and 22 other countries.
The recalled units have an undersized spigot bore diameter, a manufacturing defect that prevents proper separation of the proximal body from the stem. This defect may require surgical delay and risks bone damage during revision surgery when the implant must be removed.
The defect affects 51 specific lot numbers (9793035 through 9887446). Healthcare providers and patients with this implant should review their implant's lot number and contact their surgeon or DePuy Orthopaedics to discuss options and next steps.
The recalled product
- Product
- GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 432
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 # s 9793035
- 9802134
- 9802135
- 9802136
- 9802137
- 9802138
- 9802139
- 9802140
- 9802141
- 9802142
- 9802143
- 9802144
- 9802145
- 9802146
- 9802147
- 9802148
- 9802149
- 9802150
- 9802151
- 9814515
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.
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