RecallRadar

FDA Device recall Z-0253-2018

Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthros…

On 2017-12-20 the FDA classified a Class II recall of Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthros… by Conmed, citing manufactured with the incorrect anchor outer body.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0253-2018
ClassificationClass II
Statusterminated
Initiated2017-04-17
Published2017-12-20
Last updated2026-09-13 11:54 UTC
CompanyConmed
DistributionCA, IN, KS, MD, NY, OH, PA, TN, TX, WI

Product

Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.

Reason

Manufactured with the incorrect anchor outer body

Identifiers

code_infoLot Number 786351

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0253-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.