Hip Stem Component Recalled Due to Undersized Bore Diameter
DePuy is recalling GLOBAL UNITE STD STEM SZ 6 orthopedic stems due to undersized spigot bore that may prevent safe removal during revision surgery, risking surgical delays 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 recall of an orthopedic implant with a manufacturing defect affecting structural integrity and removal capability. The defect creates documented risk of surgical delay and bone damage during revision procedures, qualifying as a 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 6 orthopedic stem component (Part Number 11000610). The affected units were distributed worldwide, including throughout the United States and internationally to 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 stems may have an undersized spigot bore diameter. This manufacturing defect may prevent separation of the proximal body from the stem without surgical delay and/or bone damage. If revision surgery is needed and the stem cannot be properly separated, surgeons may encounter extended operative time and inadvertent bone damage during removal.
Patients who have received this implant should consult their surgeon to determine if their device is affected. The recalled lot numbers are: 9792595, 9793039, 9802121, 9813506, 9818509, 9830922, 9840359, and 9858603. Healthcare providers should contact DePuy Orthopaedics for guidance on management of affected devices.
No injuries or illnesses have been reported in association with this defect.
The recalled product
- Product
- GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 28
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 (7)
- Lot #: 9792595
- 9793039
- 9802121
- 9813506. 9818509
- 9830922
- 9840359
- 9858603 GTIN: 10603295004011
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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