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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86746

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 12, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ConMed Corporation

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

Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100

Z-0650-2021
Recall number
Z-0650-2021
Initiated
November 12, 2020
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
73 total: 23 units US;50 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system

Code information

Lot Codes: 201926AB 201942AF 201947AF 202007AF 202011 AF 202015AF 202018AF 202024AF

Distribution pattern

Nationwide Foreign: Canada, Thailand, Taiwan, South Africa

device · product 2 of 2

Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100

Z-0651-2021
Recall number
Z-0651-2021
Initiated
November 12, 2020
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
95 total: 20 units US and 75 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system

Code information

Lot Codes: 201941AE 201946AF 202006AF 202010AF 202015AF 202019AF 202023AF

Distribution pattern

Nationwide Foreign: Canada, Thailand, Taiwan, South Africa