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FDA (Device enforcement)Recalled 2024-01-24class ii

Synthes (USA) Products LLC: Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S

Hazard

Products not sterilized, sterility cannot be confirmed

Details from the source

Reason for recall: Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa. Quantity: 30 units Lot/code info: UDI: 07611819318489 Lot Number: 427P153

UPC codes

07611819318489

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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