Recall events
/
Event 52634
Event summary
Timeline bucket January 05, 2009
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording NuVasive 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
31 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 31
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0348-2013
Recall number Z-0348-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0348-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[25807]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2069, JK2085, JK2102, JK2188, JK2171
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16446]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 31
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0349-2013
Recall number Z-0349-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0349-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[54062]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2053
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16003]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 31
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0350-2013
Recall number Z-0350-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0350-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[43938]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2051, JK2154
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[17019]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 31
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0351-2013
Recall number Z-0351-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0351-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6603]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2042, JK2080, JK2151
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[15894]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 31
5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0352-2013
Recall number Z-0352-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0352-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[43933]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2058, JK2054, JK2081, JK2143
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16959]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 31
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0353-2013
Recall number Z-0353-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0353-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[54064]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2082, JK2095, JK2165
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16015]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 31
5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0354-2013
Recall number Z-0354-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0354-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[25808]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2059, JK2084, JK2148
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[21758]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 31
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0355-2013
Recall number Z-0355-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0355-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[30991]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2057, JK2157.
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[15783]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 31
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0356-2013
Recall number Z-0356-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0356-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[12900]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2083, JK2184
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[15997]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0357-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0357-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6599]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2052, JK2070, JK2098, JK2160, JK2093, JK2159
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[15884]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0358-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0358-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6601]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2071, JK2169, JK2167.
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[21696]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0359-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0359-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[48819]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2039, JK2072, JK2168.
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[15765]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0360-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0360-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[54063]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2060, JK2046, JK2180, JK2202, JK2213, JK2230, JK2231, JK2247, JK2244
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[21492]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0361-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0361-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6596]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2094, JK2096
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[21478]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0362-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0362-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[48812]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2097, JK2190
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[21742]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0363-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0363-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[43936]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2098, JK2187
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16094]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0364-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0364-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[48813]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2099, JK2186
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16079]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0365-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0365-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[54066]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2056, JK2100, JK2162
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16499]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0366-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0366-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[48822]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2101, JK2163
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[17048]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0367-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0367-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[48815]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK1949, JK2068, JK2071, JK2078, JK2079, JK2170, JK2206, JK2375, JK2387, JK2398, JK2400
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16158]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0368-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0368-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6602]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2035, JK2131, JK2349
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[21524]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0369-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0369-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[12892]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2036, JK2132, JK2350.
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16020]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0370-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0370-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[19805]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2037, JK2130, JK2037, JK2366
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[17051]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0371-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0371-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[54067]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2043, JK2134, JK2364, JK2367
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[21772]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0372-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0372-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[43935]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2044, JK2144, JK2378, JK2144
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16143]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0373-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0373-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[48823]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2055, JK2142, JK2172, JK2174, JK2192, JK2212, JK2173.
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[21685]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0374-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0374-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[36716]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2045, JK2038, JK2140, JK2361, JK2362, JK2365, JK2368, JK2370, JK2369, JK2377, JK2379
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16137]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0375-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0375-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[19806]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: 2008400621, JK2039, JK2141, JK2191, JK2177, JK2178, JK2179, JK2181, JK2182, JK2183, JK2141, JK2181
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[15905]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0376-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0376-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6598]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2040, JK2147, JK2381, JK2141
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16432]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0377-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0377-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[30990]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2047, JK2152, JK2383, JK2394
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16495]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0378-2013
Initiated January 05, 2009
Classification Class II
Status Terminated
Quantity 240 units total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The tulip portion of the screw assembly can disengage from the shank after implantation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Device Design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0378-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[43931]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information Batch: JK2041, JK2146, JK2396, JK2397
Distribution pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
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[16000]
FDA event record
· Exact recall-number query on openFDA
