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Wright Medical Technology, Inc. Recall 92460

Description: Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

Wright Medical Technology, Inc. Recall 92460 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2105-2023
Event ID92460
Event DescriptionStryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Product TypeDevices
DistributionThere 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.
Quantity106 devices
Recall ReasonThe 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.
Device Classification20230712
Device Code InfoLot numbers 2656815 and 2762126, UDI-DI 00889797003926.
Center Classification Date20230706
Recall Initiation Date20230613
Recalling FirmWright Medical Technology, Inc.
Initial Notification E-Mail
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