—#203590

Product

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix

FDA product code: MBP — Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051195
Affected lot / code info: a) T43102: b) T43102INT: c) T43103INT: d) T43105: e) T43105INT: f) T43110: g) T43110INT:

Why it was recalled

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Root cause (FDA determination)

Employee error

Action the firm took

Medtronic issued an URGENT: MEDICAL PRODUCT RECALL notice to its consignees on 09/26/2023 via UPS 2-day delivery. The notice explained the problem, potential risk, and requested the return of the affected devices.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern: US, Colombia, S. Korea, New Zealand, India, Taiwan

Timeline

Recall initiated: 2023-09-26
Posted by FDA: 2023-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203590. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.