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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81059

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

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Event summary

Timeline bucket
August 30, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Mitek, Inc., a Johnson & Johnson Co.

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

Mitek Screw and Washer Depth Gauge, Product Code 219024

Z-0208-2019
Recall number
Z-0208-2019
Initiated
August 30, 2018
Classification
Class II
Status
Terminated
Quantity
401

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.

Code information

UDI: 10886705005390; Lot Numbers: 0005178 1103107 0009101 1105132 0009181 1112106 0102157 1201104 0103045 950229 0205355 961232 0207451 970198 0208597 971229 0301615 980585 0302184 9809121 0303337 990765 0311333 C000007655 0311389 C000012527 0512552 C000020182 0605571 1000196842 0612501 1000415749 0707512 1000431580 0710501 1000661713 0801536 1001119996 0809117 1002144 0905130 1006113 0912100 1008120 1000064514 1103103

Distribution pattern

US nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI. The products were distributed to the following foreign countries: Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Japan, Jordan, Netherlands, Poland, Slovenia, Sweden, Turkey, UK.