Exact FDA event identifier

Event 82193

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 19, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Smith & Nephew, 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

2 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 2

smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510

Z-1028-2019

Recall number: Z-1028-2019
Initiated: February 19, 2019
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 58 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

Code information

Batch Numbers: 11AM15163U, 11AM15184T, 11CM01097U, 15MM06466, 16EM13018, 16EM13035 & 18CM08027

Distribution pattern

US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain

device · product 2 of 2

smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511

Z-1029-2019

Recall number: Z-1029-2019
Initiated: February 19, 2019
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

Code information

11CM01091T, 11EM12764T, 11EM12764U, 13MM16036B, 14GM13037D, 15MM09360A, 15MM10833A, 18CM24036 & 18EM15257

Distribution pattern

US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain