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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85036

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

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Event summary

Timeline bucket
May 03, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
XTANT MEDICAL 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

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

OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.

Z-1526-2020
Recall number
Z-1526-2020
Initiated
May 03, 2019
Classification
Class II
Status
Terminated
Recalling firm
XTANT MEDICAL INC
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.

Code information

Lot/Serial numbers: B180228-751 through B180228-779;Model/Product Code: 359100;the expiration date of these devices is 2021-06-05.

Distribution pattern

US Nationwide Distribution in the states of AZ,CA, NC, NJ, NY, PA, SC, TX, and WA. There were no OUS consignees.