RecallRadar

FDA Device recall Z-3176-2018

Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

On 2018-09-26 the FDA classified a Class II recall of Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612 by Zimmer Biomet, citing the Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-3176-2018
ClassificationClass II
Statusterminated
Initiated2018-07-20
Published2018-09-26
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionIN, TN

Product

Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

Reason

The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.

Identifiers

code_infoLot Number 611330, UDI (1)00880304008526(17)221010(10)611330

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-3176-2018%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.