Recall events
/
Event 94215
Event summary
Timeline bucket February 27, 2024
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
12 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 12
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
Z-1621-2024
Recall number Z-1621-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1621-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46477]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327380897(17)290313(10) Lot Number: 14974852
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34215]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 12
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Z-1622-2024
Recall number Z-1622-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 45 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1622-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5203]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327380903(17)290313(10) Lot Number: 14875651 15005253 16044255
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[31688]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 12
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Z-1623-2024
Recall number Z-1623-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1623-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57885]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327381047(17)290313(10) Lot Number: 14629051 14628851 15175654 15610452
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32458]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 12
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
Z-1624-2024
Recall number Z-1624-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 48 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1624-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16480]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327380859(17)290313(10 Lot Number: 14875853 14875852
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34564]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 12
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
Z-1625-2024
Recall number Z-1625-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 225 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1625-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34943]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI:(01)07613327380880(17)290313(10) Lot Number: 15293151 15293153 15293152 15432252 15432254 15432451 15432351 15432251 15432253 16265752
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32592]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 12
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Z-1626-2024
Recall number Z-1626-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1626-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46478]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327380958(17)290313(10) Lot Number: 15854353
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32464]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 12
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
Z-1627-2024
Recall number Z-1627-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1627-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28806]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327380835(17)290313(10) Lot Number: 15445252
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36153]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 12
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Z-1628-2024
Recall number Z-1628-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1628-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40692]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327380941(17)290313(10) Lot Number: 16311453
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32435]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 12
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
Z-1629-2024
Recall number Z-1629-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1629-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51556]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI:(01)07613327381009(17)290313(10) Lot Number: 14593551 15432653 15432651
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32588]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1630-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1630-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5565]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327381023(17)290313(10) Lot Number: 14876553 14876552
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34629]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1631-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1631-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28808]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327380811(17)290313(10) Lot Number: 13927651
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34542]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1632-2024
Initiated February 27, 2024
Classification Class II
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1632-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16478]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information UDI-DI: (01)07613327380927(17)290313(10) Lot Number: 15611151
Distribution pattern Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[31704]
FDA event record
· Exact recall-number query on openFDA
