FDAClass IIJune 5, 2024

STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Inte recall

STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part…

Why was STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Inte recalled?

Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay

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: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252

Product
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part…
Recalling firm
Synthes (USA) Products LLC
Quantity
261 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall date
June 5, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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