Exact FDA event identifier

Event 80845

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

Event summary

Timeline bucket: July 12, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Orthosensor, 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

6 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 6

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.

Z-0082-2019

Recall number: Z-0082-2019
Initiated: July 12, 2018
Classification: Class II
Status: Terminated
Recalling firm: Orthosensor, Inc.
Quantity: 41 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Some sensors were reported to have fluid inside the posterior lateral corner post-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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Code information

Lot numbers 20568, 20575, 20581, 20584, 20621, 20623, and 20628, UDI 00816818021430.

Distribution pattern

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

device · product 2 of 6

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.

Z-0083-2019

Recall number: Z-0083-2019
Initiated: July 12, 2018
Classification: Class II
Status: Terminated
Recalling firm: Orthosensor, Inc.
Quantity: 37 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Some sensors were reported to have fluid inside the posterior lateral corner post-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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Code information

Lot numbers 20569, 20576, 20594, and 20618, UDI 00816818021447.

Distribution pattern

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

device · product 3 of 6

OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.

Z-0084-2019

Recall number: Z-0084-2019
Initiated: July 12, 2018
Classification: Class II
Status: Terminated
Recalling firm: Orthosensor, Inc.
Quantity: 56 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Some sensors were reported to have fluid inside the posterior lateral corner post-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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Code information

Lot numbers 20579, 20601, and 20602, UDI 00816818021416.

Distribution pattern

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

device · product 4 of 6

OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.

Z-0085-2019

Recall number: Z-0085-2019
Initiated: July 12, 2018
Classification: Class II
Status: Terminated
Recalling firm: Orthosensor, Inc.
Quantity: 36 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Some sensors were reported to have fluid inside the posterior lateral corner post-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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Code information

Lot numbers 20598 and 20607, UDI 00816818021423.

Distribution pattern

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

device · product 5 of 6

OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.

Z-0086-2019

Recall number: Z-0086-2019
Initiated: July 12, 2018
Classification: Class II
Status: Terminated
Recalling firm: Orthosensor, Inc.
Quantity: 84 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Some sensors were reported to have fluid inside the posterior lateral corner post-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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Code information

Lot numbers 20549, 20565, 20606, 20610, 20615, UDI 00816818021454.

Distribution pattern

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

device · product 6 of 6

OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.

Z-0087-2019

Recall number: Z-0087-2019
Initiated: July 12, 2018
Classification: Class II
Status: Terminated
Recalling firm: Orthosensor, Inc.
Quantity: 68 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Some sensors were reported to have fluid inside the posterior lateral corner post-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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Code information

Lot numbers 20566, 20567, 20609, and 20611, UDI 00816818021461.

Distribution pattern

Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.