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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89456

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

Open FDA event record

Event summary

Timeline bucket
December 21, 2021
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

32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032

Z-0644-2022
Recall number
Z-0644-2022
Initiated
December 21, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the outer Tyvek lid to de-bond from the sealed package.

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

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Code information

UDI: 07613327012842; Lot Number: 87327407

Distribution pattern

Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.

device · product 2 of 2

Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

Z-0645-2022
Recall number
Z-0645-2022
Initiated
December 21, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the outer Tyvek lid to de-bond from the sealed package.

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

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Code information

UDI: 07613327013306; Lot Number: 87458602

Distribution pattern

Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.