The Recall Desk
SevereFDA (Devices)·Z-0793-2016·Announced 2016-02-17

Smith & Nephew BEAVER Blade 4.0mm Recalled for Fracture Risk

Smith & Nephew is recalling BEAVER Blade 4.0mm orthopedic instruments because they may fracture during hip arthroscopy procedures.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fracture) in a surgical instrument, which poses a significant risk of injury during a procedure.

Plain-English summary

Smith & Nephew, Inc. is recalling 69,043 units of the BEAVER Blade 4.0mm (Part Number: 72203307). This orthopedic surgical instrument is used in hip arthroscopy procedures. The recall is due to reports of the blade exhibiting fracture during use.

The affected products were distributed worldwide, including in the United States and numerous other countries. The source text lists specific lot codes for devices within their expiry dates. No specific dates of distribution or specific patient injury counts are provided in the source text.

Healthcare providers and patients should stop using the affected blades immediately. Smith & Nephew is the recalling firm and is responsible for managing the recall. Users should contact the manufacturer for instructions on returning or replacing the devices.

The recalled product

Product
Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.
Affected units
69,043

Distribution

Distributed nationwide across the United States.