Orthopedic implant components recalled due to sterilization failure
Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.
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 recall with no reported illnesses or injuries. The hazard—sterility failure in surgical implants that could cause infection—remains theoretical pending implantation. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).
Plain-English summary
Encore Medical, LP is recalling DJO Surgical Altivate Reverse orthopedic implants (Humeral Stem, Small Shell, Size 6 x 108mm, REF 533-06-108) due to sterilization process failure. A total of 15 units were not subjected to final sterilization before shipment.
The affected lot (UDI-DI 00190446259091, Lot 923W1411, April 3, 2029) was distributed to healthcare facilities across the United States (Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, Virginia, and Washington) and internationally (Sweden, Australia, France, United Kingdom, Colombia, and Germany).
If implanted, unsterilized components may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery.
The recalled product
- Product
- DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
- Manufacturer
- Encore Medical, LP
- Affected units
- 15
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: 00190446259091/923W1411/April 3
- 2029
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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