Exact FDA event identifier

Event 79038

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

Event summary

Timeline bucket: July 21, 2017
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

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

Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737

Z-0940-2018

Recall number: Z-0940-2018
Initiated: July 21, 2017
Classification: Class II
Status: Terminated
Recalling firm: Howmedica Osteonics Corp.
Quantity: 255

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inner and outer sterile barriers not fully sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inner and outer sterile barriers not fully sealed.

Code information

Lot: 56211103, 56211401, 56211704, 57284004

Distribution pattern

Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.

device · product 2 of 2

Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535

Z-0941-2018

Recall number: Z-0941-2018
Initiated: July 21, 2017
Classification: Class II
Status: Terminated
Recalling firm: Howmedica Osteonics Corp.
Quantity: 255

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inner and outer sterile barriers not fully sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inner and outer sterile barriers not fully sealed.

Code information

Lot: 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304

Distribution pattern

Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.