Exact FDA event identifier

Event 91913

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

Event summary

Timeline bucket: March 10, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Howmedica Osteonics Corp.

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

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

Z-1385-2023

Recall number: Z-1385-2023
Initiated: March 10, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Howmedica Osteonics Corp.
Quantity: 52 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

Code information

GTIN 00848486003746, Lot Number 26270421

Distribution pattern

U.S., Netherlands, Japan, China, India, Korea, and Australia.

device · product 2 of 2

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure

Z-1386-2023

Recall number: Z-1386-2023
Initiated: March 10, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Howmedica Osteonics Corp.
Quantity: 102 units