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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63557

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 25, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Kerr 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

1 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 1

BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.

Z-0401-2013
Recall number
Z-0401-2013
Initiated
October 25, 2012
Classification
Class II
Status
Terminated
Recalling firm
Kerr Corporation
Quantity
22,410 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.

Code information

The BioPlant part numbers and lot numbers affected by this recall are as follows: Product Description Part Numbers Lot Numbers BioPlant Curved Syringe, 0.125g 216110 All Production BioPlant Curved Syringe, 0.25g 216112 BioPlant Curved Svrinoe, 0.50<1 216114 Lots Within Shelf-Life BioPlant Curved Svrinoe, 0.250 216132 20k BioPlant Intro Pack 216112S

Distribution pattern

Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .