Z-2481-2023Class II

Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee...

Name: Z-2481-2023 Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2023-07-26
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2023-07-26 / Open, Classified / root cause: design

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty... on 2023-07-26. FDA classified it as Class II and gives the reason as "A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2481-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-26
Posted: 2023-08-29
Recalling firm: Waldemar Link GmbH & Co. KG
Product: Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery
Root cause tag: design
FDA root cause: Device Design
Action: LinkBio Corp.(US Importer) issued Urgent: Medical Device Recall letter via email on July 27, 203 to US Distributors . Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or [email protected] for any questions.
Quantity in commerce: 6 units
Distribution: IN,GA, TX
Product codes and lots: UDI-DI: 04026575284658 Lot Codes: C010108, C151519

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2481-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2481-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-29

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)