Exact FDA event identifier

Event 81192

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

Open FDA event record

Event summary

Timeline bucket: September 10, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
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

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

Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.

Z-0373-2019

Recall number: Z-0373-2019
Initiated: September 10, 2018
Classification: Class II
Status: Terminated
Recalling firm: Howmedica Osteonics Corp.
Quantity: 15 pouches

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

sterile barrier to be compromised

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

Potential for outer pouch sterile barrier to be compromised

Code information

Lot SC22130X Exp 2023-08-05

Distribution pattern

US Nationwide in the states of AL, FL, IL, MI, NJ & OH.