FDAClass IIMarch 26, 2025

Total HIP Pack recall

TOTAL HIP PACK , Model No SMTH06O SMTH06P

Why was Total HIP Pack recalled?

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI 00191072163882 00191072229601 Lots 969241 928241 70-051508 70-052517

Product
TOTAL HIP PACK , Model No SMTH06O SMTH06P
Recalling firm
American Contract Systems Inc
Quantity
24 kits
Distribution
US Nationwide distribution in the state of OH.
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls