Z-0769-2025Class II

LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126...

Name: Z-0769-2025 LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2024-12-05
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2024-12-05 / Open, Classified / root cause: labeling and UDI

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item... on 2024-12-05. FDA classified it as Class II and gives the reason as "Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0769-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-05
Posted: 2024-12-26
Recalling firm: Waldemar Link GmbH & Co. KG
Product: LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Link Bio Corp. Dover, NJ issued Urgent Medical Device Recall to Consignees via email on December 5, 2024. 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. 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: 3 units
Distribution: US Nationwide distribution in the states of AL, FL.
Product codes and lots: UDI-DI: 04026575409785 Serial Numbers: 170418/1971 231113/2472 240219/0512 240311/0727 170515/1335 231113/2473 240219/0513 240311/0729 170717/1773 231113/2474 240219/0514 240311/0730 180219/1681 231113/2475 240219/0515 240311/0731 180219/1687 231113/2476 240219/0516 240311/0732 211122/0489 231113/2478 240219/0518 240311/0733 231113/2462 231113/2479 240219/0519 240311/0734 231113/2463 240219/0505 240219/0520 240311/0735 231113/2464 240219/0506 240219/0521 240311/0736 231113/2465 240219/0507 240219/0522 240311/0737 231113/2466 240219/0508 240219/0523 240311/0738 231113/2467 240219/0509 240219/0524 240311/0739 231113/2468 240219/0510 240219/0525 240311/0740 231113/2469 240219/0511 240219/0526 240311/0741 231113/2470 240311/0742 240311/0726

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0769-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0769-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-26

Product code LZO

K142187Class IILink Mp Reconstruction ProsthesisWaldemar Link GmbH & Co. KG / cleared 2014-11-06

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)