DJO Surgical Orthopedic Implants Recalled for Sterilization Failure
DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.
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: Class II device with manufacturing defect (lack of sterilization) that could cause infection if implanted. No illnesses or injuries reported to date; the hazard is theoretical. Meets criteria for High severity as a risk-of-harm product without reported injury.
Plain-English summary
DJO Surgical Delta Ceramic Femoral Head implants (10 units, lot 878B1171, model REF: 400-03-443) manufactured by Encore Medical, LP have been recalled. The devices were not subjected to final sterilization before shipment.
If implanted, non-sterile devices may lead to varying degrees of infection, which may require medical treatment, prolonged monitoring, and may lead to revision surgery.
The affected devices were distributed to medical facilities in 25 U.S. states and in Sweden, Australia, France, the United Kingdom, Colombia, and Germany. Patients or healthcare providers who may have received these implants should verify the lot number (878B1171) and contact their healthcare provider or manufacturer for guidance on appropriate follow-up.
The recalled product
- Product
- DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
- Manufacturer
- Encore Medical, LP
- Affected units
- 10
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 (2)
- UDI-DI/Lot/Expiration: 00888912076210/878B1171/May 2
- 2027
Distribution
Part of a larger recall action
This product is one of 5 recalled by Encore Medical, LP 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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