The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1334-2023·Announced 2023-04-12

Medtronic XPANSE Bone Insert Recalled for Sterile Packaging Non-Conformances

Medtronic is recalling XPANSE Bone Insert products due to packaging defects that may compromise the sterile barrier. Non-sterile packaging could allow contamination before surgical implantation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of surgical implants with potential for sterility compromise and contamination risk without reported injury. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Sofamor Danek USA Inc. is recalling multiple XPANSE Bone Insert products due to potential non-conformances in the sterile pouch packaging system. Affected models include XPANSE SMALL-C 6, XPANSE MEDIUM-C 6, XPANSE MEDIUM-C 9, XPANSE LARGE-C 6, and XPANSE LARGE-C 9, with 4,348 units distributed worldwide.

The packaging non-conformances are related to the dual-barrier sterile pouch system designed to maintain product sterility. A breach in the sterile barrier could allow contamination of the bone graft material before surgical implantation.

These demineralized bone matrix (DBM) products are used as bone graft substitutes in orthopedic spinal fusion surgery. Affected units were distributed to hospitals and surgical facilities in the United States and numerous international locations. Healthcare providers should verify the serial numbers of their inventory against the recall list provided by Medtronic.

Patients who have received these implants should consult their healthcare provider if they have concerns about their implant or surgical procedure.

The recalled product

Product
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309…
Manufacturer
Medtronic Sofamor Danek USA Inc
Category
Medical Device — Orthopedic Bone Graft
Hazard
Affected units
4,348

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) DBM T600106 XPANSE SMALL-C 6
  • REF T600106
  • GTIN 00643169218314
  • Serial Numbers: A41747-061
  • A41747-062
  • A41747-063
  • A41747-064
  • A41747-065
  • A41747-066
  • A41747-067
  • A41747-068
  • A41747-069
  • A41747-070
  • A41747-071
  • A41747-072
  • A41747-073
  • A43745-061
  • A43745-062
  • A43745-063
  • A43745-064

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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