Recall events
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Event 74850
Event summary
Timeline bucket July 18, 2016
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Medtronic Sofamor Danek USA Inc
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
8 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 8
RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,
Z-2631-2016
Recall number Z-2631-2016
Initiated July 18, 2016
Classification Class II
Status Terminated
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2631-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34222]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Distribution pattern AR, MN,MA
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[10775]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 8
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
Z-2632-2016
Recall number Z-2632-2016
Initiated July 18, 2016
Classification Class II
Status Terminated
Quantity 3
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2632-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10492]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Distribution pattern AR, MN,MA
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[7615]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 8
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
Z-2633-2016
Recall number Z-2633-2016
Initiated July 18, 2016
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2633-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10494]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Distribution pattern AR, MN,MA
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[7623]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 8
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
Z-2634-2016
Recall number Z-2634-2016
Initiated July 18, 2016
Classification Class II
Status Terminated
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2634-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45527]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Code information P239049, P239142
Distribution pattern AR, MN,MA
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[10711]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 8
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
Z-2635-2016
Recall number Z-2635-2016
Initiated July 18, 2016
Classification Class II
Status Terminated
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2635-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38462]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Code information P239166, P239167,
Distribution pattern AR, MN,MA
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[7733]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 8
TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
Z-2636-2016
Recall number Z-2636-2016
Initiated July 18, 2016
Classification Class II
Status Terminated
Quantity 3 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2636-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15642]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Code information P236112, P239165
Distribution pattern AR, MN,MA
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[7600]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 8
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Z-2637-2016
Recall number Z-2637-2016
Initiated July 18, 2016
Classification Class II
Status Terminated
Quantity 2 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2637-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38465]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Code information P239168, P239169
Distribution pattern AR, MN,MA
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[7605]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 8
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Z-2638-2016
Recall number Z-2638-2016
Initiated July 18, 2016
Classification Class II
Status Terminated
Quantity 1 unit
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2638-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45531]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Distribution pattern AR, MN,MA
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[10801]
FDA event record
· Exact recall-number query on openFDA
