Orthopedic hip stem implant recalled due to sterilization failure
Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially 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 FDA Class II recall involves surgical implants lacking sterilization, which poses a risk of post-implant infection requiring potential treatment and revision surgery. However, the source text reports no confirmed illnesses or injuries, making this a theoretical hazard. Per the severity rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Encore Medical, LP has recalled DJO Surgical CLP Hip Stem implants (Size #3, REF: 426-11-030, Lot 415N1014, expiration May 3, 2028) because the orthopedic device components were not subjected to final sterilization before shipment.
Non-sterilized surgical implants may cause infection of varying severity if implanted. These infections may require treatment, prolonged medical monitoring, and in some cases may necessitate revision surgery.
The affected implants were distributed throughout the United States and internationally to Sweden, Australia, France, the United Kingdom, Colombia, and Germany.
Patients who have received this implant should contact their healthcare provider or the manufacturer for guidance regarding potential infection risks and to determine whether evaluation or intervention is needed.
The recalled product
- Product
- DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
- Manufacturer
- Encore Medical, LP
- Category
- Medical Device — Hip Implant
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: 00888912079631/415N1014/May 3
- 2028
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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