RecallRadar

FDA Device recall Z-0325-2018

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

On 2018-01-17 the FDA classified a Class II recall of Mac Pin Non-Cannulated Screw, 6.5 x 60mm by Amendia, citing incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0325-2018
ClassificationClass II
Statusterminated
Initiated2017-07-07
Published2018-01-17
Last updated2026-09-13 11:54 UTC
CompanyAmendia
DistributionGA

Product

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Reason

Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

Identifiers

code_infoModel #85-6560-1, Lot #132117

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-0325-2018%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.