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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74053

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

Open FDA event record

Event summary

Timeline bucket
May 02, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes (USA) Products 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

3 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 3

1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.

Z-1918-2016
Recall number
Z-1918-2016
Initiated
May 02, 2016
Classification
Class II
Status
Terminated
Quantity
22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

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

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Code information

Catalog # 851.689.01S, Lot # 7672066 and 7672089

Distribution pattern

Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.

device · product 2 of 3

1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.

Z-1919-2016
Recall number
Z-1919-2016
Initiated
May 02, 2016
Classification
Class II
Status
Terminated
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

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

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Code information

Catalog # 851.690.01S, Lot # 6904416, 6904418, 7672126

Distribution pattern

Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.

device · product 3 of 3

1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.

Z-1920-2016
Recall number
Z-1920-2016
Initiated
May 02, 2016
Classification
Class II
Status
Terminated
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

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

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Code information

Catalog # 851.691.01S, Lot # 6123191, 6913455, 7540885

Distribution pattern

Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.