RecallRadar

FDA Device recall Z-1377-2013

***REF S-3D*** 3mm Diamond Ball

On 2013-06-05 the FDA classified a Class II recall of ***REF S-3D*** 3mm Diamond Ball by The Anspach Effort, citing due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1377-2013
ClassificationClass II
Statusterminated
Initiated2011-03-04
Published2013-06-05
Last updated2026-09-13 11:53 UTC
CompanyThe Anspach Effort
DistributionUS

Product

***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.

Reason

Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

Identifiers

code_infoLots numbers: D433040800, D403040236, D383039472.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1377-2013%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.