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.
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 6
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
Distribution pattern
Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.
device · product 2 of 6
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
Distribution pattern
Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.
device · product 3 of 6
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
Distribution pattern
Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.
device · product 4 of 6
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
Distribution pattern
Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.
device · product 5 of 6
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
Distribution pattern
Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.
device · product 6 of 6
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
Distribution pattern
Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.
