The Recall Desk
Agency classClass IIOur severity: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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.

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