Recall events
/
Event 65800
Event summary
Timeline bucket July 16, 2013
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Waldemar Link GmbH & Co. KG (Corp. Hq.)
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
21 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 21
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2060-2013
Recall number Z-2060-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2060-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[53719]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B208030, B225121
Distribution pattern US Distribution to the state of Tennessee only.
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[16396]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 21
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2061-2013
Recall number Z-2061-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2061-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[25951]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B208031
Distribution pattern US Distribution to the state of Tennessee only.
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[16392]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 21
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2062-2013
Recall number Z-2062-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 6 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2062-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[25957]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B226105, B128103
Distribution pattern US Distribution to the state of Tennessee only.
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[19950]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 21
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2063-2013
Recall number Z-2063-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2063-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[25959]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B208032
Distribution pattern US Distribution to the state of Tennessee only.
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[17216]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 21
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2064-2013
Recall number Z-2064-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2064-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[43071]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B208033
Distribution pattern US Distribution to the state of Tennessee only.
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[16656]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 21
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2065-2013
Recall number Z-2065-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2065-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[12923]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B208034
Distribution pattern US Distribution to the state of Tennessee only.
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[17213]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 21
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2066-2013
Recall number Z-2066-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2066-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[25956]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B208035
Distribution pattern US Distribution to the state of Tennessee only.
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[19955]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 21
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2067-2013
Recall number Z-2067-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 6 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2067-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[53714]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B048087, B225117
Distribution pattern US Distribution to the state of Tennessee only.
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[24995]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 21
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2068-2013
Recall number Z-2068-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 7 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2068-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20223]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B208036, B225081
Distribution pattern US Distribution to the state of Tennessee only.
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[21434]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2069-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 9 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2069-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[31053]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B226103, B051034
Distribution pattern US Distribution to the state of Tennessee only.
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[19960]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2070-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2070-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[7090]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B208089, B225125
Distribution pattern US Distribution to the state of Tennessee only.
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[22325]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2071-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2071-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[31051]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B209033, B225119
Distribution pattern US Distribution to the state of Tennessee only.
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[22322]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2072-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2072-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[53711]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B209034, B225123
Distribution pattern US Distribution to the state of Tennessee only.
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[22317]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2073-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2073-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20216]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B209035, B225120
Distribution pattern US Distribution to the state of Tennessee only.
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[16654]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2074-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2074-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[37086]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B208037, B225126
Distribution pattern US Distribution to the state of Tennessee only.
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[16413]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2075-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 6 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2075-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20218]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B225082, B126052
Distribution pattern US Distribution to the state of Tennessee only.
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[19947]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2076-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 6 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2076-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[1636]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B225116, B128075
Distribution pattern US Distribution to the state of Tennessee only.
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[21443]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2077-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 9 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2077-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[53715]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B225114, B051033, B103049
Distribution pattern US Distribution to the state of Tennessee only.
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[22331]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2078-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 8 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2078-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[37084]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B225118, B101171
Distribution pattern US Distribution to the state of Tennessee only.
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[22314]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2079-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 9 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2079-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[37089]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B225115, B048089, B102030
Distribution pattern US Distribution to the state of Tennessee only.
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[17632]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2080-2013
Initiated July 16, 2013
Classification Class II
Status Terminated
Quantity 8 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The trial stems were manufactured using the wrong design.
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-2080-2013
Source locator 0001-device-recall-0001-of-0001.json.zip#results[37088]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The trial stems were manufactured using the wrong design.
Code information Lots: B206025, B048090, B101172
Distribution pattern US Distribution to the state of Tennessee only.
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[21439]
FDA event record
· Exact recall-number query on openFDA
