DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
Lot Codes / Batch Numbers
UDI-DI/Lot/Expiration: 00888912079631/415N1014/May 3, 2028
Products Sold
UDI-DI/Lot/Expiration: 00888912079631/415N1014/May 3, 2028
A medical device manufacturer is recalling DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030 due to Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, w. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Recommended Action
Per FDA guidance
On 8/4/23, recall notices were mailed to surgeons and distributors. They were reminded that starting on 7/3/23 they were contacted by the firm, and asked to quarantine affected devices, and that the affected devices had since been retrieved by the firm's sales representatives. Surgeons were asked to take the following actions: 1) We ask that you reach out to your patient[s] who were implanted with affected components as identified above and consider whether it may be appropriate for your patient to be monitored more closely to watch for signs and symptoms of acute or chronic infection. 2) We have also provided a patient letter for you to provide to your patient[s] who was [were] implanted with an affected component[s] should you prefer a written notification to accompany your verbal contact. 3) Please make the hospital where you implanted the components aware of this action, as appropriate by providing a copy of this communication or verbally notifying the hospital. 4) Please review and complete the enclosed Voluntary Recall Response Form. If you have any questions phone the firm at 1(800)456-8696 between the hours of 7:30AM-6:00PM CST, or e-mail customerservice@djosurgical.com In addition, distributors were asked to do the following: Provide the notification to any additional organizations or members within your facility or network where devices subject to this voluntary recall may have been transferred.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NJ, NY, NC, OH, PA, RI, SC, TX, UT, VA, WA, PR
Page updated: Jan 10, 2026