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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93830

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

Open FDA event record

Event summary

Timeline bucket
December 22, 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

HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty

Z-0999-2024
Recall number
Z-0999-2024
Initiated
December 22, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

Code information

GTIN: 07613327144086 Lot NUmbers: X22V12 X22V12A X22V12D X22T13A X22T13 X22T13D X22M09D X22M09 X22M09A X21T01K X21T01M X21T01 X20T19 X20T17A X21E23E X21E23D X21E23 X21E23A X20T17 X20T19M X20C37 X20C03A X20C03 X19N44 X19M03A X19M03 X19M02 X19K25A X19K25 X19K24 X19T10 X19K01A X19K01 X19K01D X18S14A X18T28A X18T28 X18T28A1 X18S14D X18N49 X18S14 X17N33R X18C24 X18E04 X18E04A X17N33 X17N33D X17N33A X17L11 X17L11D X17L11A X16T27 X16V17 X16W06 X16W08 X16H36 X16H37A X16H37 X16E15J X16E15K X16C22 X16A06 X15V17 X15V17A X15S26 X15S26A X15M17A X15M17 X15N14A X15N14J X15L12 X15H18 X15K15 X9W16 X9W16E X9V09 X9N60M X9T20 X9T20A X9S16 X9N60P X9N25 X9N29 X9L15J X9K31 X9K09 X9E24 X9A03A X9A03 X9A03D X9A03E X8T01 X8T01A X8L28TT X8L28T X8L28 X8L28A X7M11 X7H42A X7M22 X7M11M X7K10 X7H42 X5E15 X5M45V X5T70 X5M45K X5M45 X5M45L X5H45A X5H45 X5H12 X5H12D X5L22 X5L22W X5L22W1 X5C35

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 2 of 2

HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty

Z-1000-2024
Recall number
Z-1000-2024
Initiated
December 22, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

Code information

GTIN: 07613327144093 Lot Numbers: X22H11A1 X22H11 X22E19A X22E19D X22E19 X22C19 X22C19A1 X22C19A2 X22C19A3 X21M16A X21M16 X21K12 X21K12A X20T14A1 X20P04D X20P04A X20T14A2 X20P04 X20T14 X19P17 X19P05 X19M57 X19M55D X19M55A X19M55 X19D04A X19D03 X19D04 X18T45 X18S06A X18S06 X18S06D X18N50 X18E19KA X17V14D X17V14A X18E09A X18E09 X18E19KAA1 X18E19KAA2 X17T14 X17T13 X17T14A X17K16 X17L31 X16W10 X16V16 X16V41 X16V29 X16M13 X16L13 X16L12 X16H32 X16H19 X16E12 X16C06 X16A07 X15V08 X15V08A X15N27 X15M06 X15L22 X15L03 X9K29 X15E23 X15E22 X15A04 X9V15 X9S15 X9N52E X9N52 X9N13 X9K06 X9L11 X9E25A X9E25D X9C05 X9C05Y X8L03 X8L03A X7M04 X7M07A X7M07M X7M07 X7M06 X7M04A X7H21TD X7H21T X7H23 X7K17 X7H21 X7H27 X7H27A X7A13P X7A13 X7A13PA X5T77 X5M46 X5M46L X5H43A X5H43 X5M47E X5M47T X5M47 X5L45 X5E50

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.