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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90421

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 02, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-1300-2022
Initiated
June 02, 2022
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.