Recall events
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Event 66545
Event summary
Timeline bucket October 07, 2013
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Smith & Nephew 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
2 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
Z-0130-2014
Recall number Z-0130-2014
Initiated October 07, 2013
Classification Class II
Status Terminated
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0130-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[31376]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
Code information Batch No. 13GM11272
Distribution pattern USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
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[16951]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
Z-0131-2014
Recall number Z-0131-2014
Initiated October 07, 2013
Classification Class II
Status Terminated
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0131-2014
Source locator 0001-device-recall-0001-of-0001.json.zip#results[49116]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
Code information Batch No. 13GM09505
Distribution pattern USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
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[18232]
FDA event record
· Exact recall-number query on openFDA
