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Recall Observatory FDA recall evidence

Device product

DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.

Z-1300-2022

June 02, 2022

Class II

Product summary

Firm
CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
Event
Event 90421
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1300-2022

Official wording

Reason: One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates

Code information: UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671

Distribution pattern: US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, IN, MA, MD, ME, MN, MT, NC, ND, NE, NH, NY, TN, VA, WA, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates