GP321R — Class II medical device recall Z-2088-2017

Terminated recall by Aesculap Implant Systems LLC, reported 2017-05-24, distributed nationwide. Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected

Recall number	`Z-2088-2017`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Aesculap Implant Systems LLC, Center Valley, PA, United States
Recall initiated	2017-03-28
Classified	2017-05-12
Reported by FDA	2017-05-24
Terminated	2018-02-06
Distributed	Nationwide (US)
Quantity	608 units
Reason classes	foreign material, specification failure, device malfunction
Model numbers	`GP321R`

Product

GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Reason for recall

Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2088-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.