Exact FDA event identifier

Event 85433

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

Event summary

Timeline bucket: January 28, 2020
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

JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in provisional fixation of the trial. SIZE 1, CATALOG NUMBER: REF 74035821 SIZE 2, CATALOG NUMBER: REF 74035822 SIZE 3, CATALOG NUMBER: REF 74035823 SIZE 4, CATALOG NUMBER: REF 74035824 SIZE 5, CATALOG NUMBER: REF 74035825 SIZE 6, CATALOG NUMBER: REF 74035826 SIZE 7, CATALOG NUMBER: REF 74035827 SIZE 8, CATALOG NUMBER: REF 74035828 SIZE 9, CATALOG NUMBER: REF 74035829 SIZE 10, CATALOG NUMBER: REF 74035830

Z-2132-2020

Recall number: Z-2132-2020
Initiated: January 28, 2020
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

Code information

SIZE 1, CATALOG NUMBER: REF 74035821; LOT/BATCH CODES: 19EM19112R, 19FM05587R, 19FM11174R, 19HM18075, 19HM19648, 19HM21015, 19HM21016, 19HM23242 SIZE 2, CATALOG NUMBER: REF 74035822; LOT/BATCH CODES: 19EM21573R, 19EM21573S, 19FM05589R, 19HM21031, 19HM21033, 19HM21878, 19HM21881 SIZE 3, CATALOG NUMBER: REF 74035823; LOT/BATCH CODES: 19EM21578R, 19HM19009, 19JM09476, 19JM18509, 19JM18525, 19JM21072, 19KM14473, 19KM17780 SIZE 4, CATALOG NUMBER: REF 74035824; LOT/BATCH CODES: 19EM14365R, 19EM14365S, 19FM11173, 19HM18078, 19HM19659, 19HM21861, 19JM21075, 19KM15573, 19KM1557 SIZE 5, CATALOG NUMBER: REF 74035825; LOT/BATCH CODES: 19EM14367R, 19HM18079, 19HM21855, 19KM12683 SIZE 6, CATALOG NUMBER: REF 74035826; LOT/BATCH CODES: 19EM24480R, 19HM18080, 19HM21856, 19KM21512 SIZE 7, CATALOG NUMBER: REF 74035827; LOT/BATCH CODES: 19EM14371R, 19FM01063R, 19FM11177R, 19HM18335, 19HM21873, 19HM21874, 19KM17781 SIZE 8, CATALOG NUMBER: REF 74035828; LOT/BATCH CODES: 19EM24498R, 19EM24498S, 19FM05591R, 19FM11178R, 19FM11178S, 19JM07464, 19JM07465, 19KM07278, 19KM12699 SIZE 9, CATALOG NUMBER: REF 74035829; LOT/BATCH CODES: 19EM21582R, 19FM11179R, 19GM21787, 19JM07467, 19KM07276, 19KM15575, 19KM15576 SIZE 10, CATALOG NUMBER: REF 74035830; LOT/BATCH CODES: 19EM14372R, 19FM11180, 19HM18254, 19JM07468, 19JM07470, 19JM07472, 19KM05610, 19KM15571

Distribution pattern

US Nationwide distribution.

device · product 2 of 2

JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in provisional fixation of the trial. SIZE 1, CATALOG NUMBER: REF 74035831 SIZE 2, CATALOG NUMBER: REF 74035832 SIZE 3, CATALOG NUMBER: REF 74035833 SIZE 4, CATALOG NUMBER: REF 74035834 SIZE 5, CATALOG NUMBER: REF 74035835 SIZE 6, CATALOG NUMBER: REF 74035836 SIZE 7, CATALOG NUMBER: REF 74035837 SIZE 8, CATALOG NUMBER: REF 74035838 SIZE 9, CATALOG NUMBER: REF 74035839 SIZE 10, CATALOG NUMBER: REF 74035840

Z-2133-2020

Recall number: Z-2133-2020
Initiated: January 28, 2020
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 195 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

Code information

SIZE 1, CATALOG NUMBER: REF 74035831; LOT/BATCH CODES: 19FM01064R, 19HM18082, 19HM21871, 19JM18534, 19JM21086, 19KM07281, 19KM15577 SIZE 2, CATALOG NUMBER: REF 74035832; LOT/BATCH CODES: 19EM21587R, 19FM11181R, 19HM21899, 19HM21902, 19HM21903, 19JM21089 SIZE 3, CATALOG NUMBER: REF 74035833; LOT/BATCH CODES: 19GM21768, 19HM18085, 19HM18085A, 19JM09477, 19JM18537, 19JM18540, 19JM18541, 19JM18542, 19JM18542A SIZE 4, CATALOG NUMBER: REF 74035834; LOT/BATCH CODES: 19FM11183R, 19JM07474, 19JM11137, 19JM21090, 19KM21513 SIZE 5, CATALOG NUMBER: REF 74035835; LOT/BATCH CODES: 19FM01065R, 19HM18086, 19HM18086A, 19HM18088, 19JM18491, 19JM21091, 19KM15580 SIZE 6, CATALOG NUMBER: REF 74035836; LOT/BATCH CODES: 19FM11184R, 19GM21778, 19JM07477, 19JM21093 SIZE 7, CATALOG NUMBER: REF 74035837; LOT/BATCH CODES: 19FM11185A, 19FM11185R, 19HM19006, 19JM21096, 19KM21504, 19KM21506, 19KM21509 SIZE 8, CATALOG NUMBER: REF 74035838; LOT/BATCH CODES: 19FM11191R, 19FM11191S, 19HM18091, 19HM21040, 19JM18543, 19JM21097, 19JM23714, 19KM15583 SIZE 9, CATALOG NUMBER: REF 74035839; LOT/BATCH CODES: 19FM05578R, 19HM18096, 19HM19658, 19KM05613, 19KM15584, 19KM15586 SIZE 10, CATALOG NUMBER: REF 74035840; LOT/BATCH CODES: 19HM18107, 19HM19004, 19JM23666, 19JM23674, 19JM23678, 19JM23678A, 19JM23680, 19KM12708

Distribution pattern

US Nationwide distribution.