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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80181

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Paragon 28, Inc.

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

P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

Z-2261-2018
Recall number
Z-2261-2018
Initiated
December 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Paragon 28, Inc.
Quantity
1,626

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Missing drill guide as stated in the package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Missing drill guide as stated in the package.

Code information

Part # P71-008-0808-S 8mm x 8mm x 8mm, Straight Lots 260315217A, 260322017A, 260326217A and 260326217B., Part # P71-010-1010-S 10mm x 10mm x 10mm, Straight Lots 260317717A, 260317717C, 260322017B, and 260326217D., Part # P71-108-0808-S 8mm x 8mm x 8mm, Angled, Lots 260322017C, 260322017D, 260315217B, and 260326217M. and Part # P71-110-1010-S 10mm x 10mm x 10mm, Angled Lots 260326217E, 260317717B, 260322017E, 260322017F, 260322017G, 260326217F and 260326217G.

Distribution pattern

Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.