Recall events
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Event 88325
Event summary
Timeline bucket March 19, 2021
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Aesculap Implant Systems LLC
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
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F MENISCAL COMP.T6 RM/LM 7MM
Z-2509-2021
Recall number Z-2509-2021
Initiated March 19, 2021
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Malfunction- loosening of the implant resulting in a potential revision surgery
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-2509-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33535]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution pattern US Nationwide distribution.
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[38223]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 8
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F MENISCAL COMP.T5 RM/LM 8MM; NL481 UNIVATION F MENISCAL COMP.T6 RM/LM 8MM
Z-2510-2021
Recall number Z-2510-2021
Initiated March 19, 2021
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Malfunction- loosening of the implant resulting in a potential revision surgery
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-2510-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33531]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution pattern US Nationwide distribution.
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[37677]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 8
Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; NL484 UNIVATION F MENISCAL COMP.T3 RM/LM 9MM; NL485 UNIVATION F MENISCAL COMP.T4 RM/LM 9MM; NL486 UNIVATION F MENISCAL COMP.T5 RM/LM 9MM; NL487 UNIVATION F MENISCAL COMP.T6 RM/LM 9MM
Z-2511-2021
Recall number Z-2511-2021
Initiated March 19, 2021
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Malfunction- loosening of the implant resulting in a potential revision surgery
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-2511-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26756]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution pattern US Nationwide distribution.
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[38229]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 8
Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION F MENISCAL COMP.T5 RM/LM 10MM; NL493 UNIVATION F MENISCAL COMP.T6 RM/LM 10MM
Z-2512-2021
Recall number Z-2512-2021
Initiated March 19, 2021
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Malfunction- loosening of the implant resulting in a potential revision surgery
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-2512-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4896]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution pattern US Nationwide distribution.
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[38226]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 8
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F MENISCAL COMP.T5 RM/LM 11MM NL499 UNIVATION F MENISCAL COMP.T6 RM/LM 11MM
Z-2513-2021
Recall number Z-2513-2021
Initiated March 19, 2021
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Malfunction- loosening of the implant resulting in a potential revision surgery
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-2513-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52051]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution pattern US Nationwide distribution.
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[38475]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 8
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM; NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM; NO159Z AS UNIVATION XF TIBIA CEMENTED T4 RM; NO160Z AS UNIVATION XF TIBIA CEMENTED T5 RM; NO161Z AS UNIVATION XF TIBIA CEMENTED T6 RM; NO162Z AS UNIVATION XF TIBIA CEMENTED T1 LM; NO163Z AS UNIVATION XF TIBIA CEMENTED T2 LM; NO164Z AS UNIVATION XF TIBIA CEMENTED T3 LM; NO165Z AS UNIVATION XF TIBIA CEMENTED T4 LM; NO166Z AS UNIVATION XF TIBIA CEMENTED T5 LM; NO167Z AS UNIVATION XF TIBIA CEMENTED T6 LM;
Z-2514-2021
Recall number Z-2514-2021
Initiated March 19, 2021
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Malfunction- loosening of the implant resulting in a potential revision surgery
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-2514-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45236]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution pattern US Nationwide distribution.
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[38053]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 8
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z AS UNIVATION XF FEMUR CEMENTED F1 LM; NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM; NO187Z AS UNIVATION XF FEMUR CEMENTED F3 LM; NO188Z AS UNIVATION XF FEMUR CEMENTED F4 LM; NO189Z AS UNIVATION XF FEMUR CEMENTED F5 LM
Z-2515-2021
Recall number Z-2515-2021
Initiated March 19, 2021
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Malfunction- loosening of the implant resulting in a potential revision surgery
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-2515-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15607]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution pattern US Nationwide distribution.
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[38355]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 8
Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544
Z-2516-2021
Recall number Z-2516-2021
Initiated March 19, 2021
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Malfunction- loosening of the implant resulting in a potential revision surgery
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-2516-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15600]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Malfunction- loosening of the implant resulting in a potential revision surgery
Distribution pattern US Nationwide distribution.
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[37840]
FDA event record
· Exact recall-number query on openFDA
