Wright Medical Technology, Inc.: Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

Hazard

The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

Details from the source

Reason for recall: The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes. Distribution: There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom. Quantity: 106 devices Lot/code info: Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.

UPC codes

00889797003926

Source

Official record: FDA (Device enforcement) ↗

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