Z-1378-2022Class II

Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11...

Name: Z-1378-2022 Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2022-05-24
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2022-05-24 / Open, Classified / root cause: manufacturing process

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12... on 2022-05-24. FDA classified it as Class II and gives the reason as "There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1378-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-24
Posted: 2022-07-12
Recalling firm: Waldemar Link GmbH & Co. KG
Product: Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On May 24, 2022, the firm notified affected customers via Urgent Field Safety Notice email. Customers were provided a modified surgical technique providing information for the cementing technique for Tilastan proximal spacers to minimize the risk. No product return is required.
Quantity in commerce: 3785
Distribution: Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam
Product codes and lots: UDI-DI 04026575034727 X-Small, Right; 04026575034741 Small, Right; 04026575034758 Small, Left; 04026575164042 Medium, Right; 04026575164059 Medium, Left; 04026575164028 Large, Right; Serial/Lot Numbers: 200818/1709 200818/1720 201013/0291 200513/2160 200818/1732 200623/4154 200812/1511 210302/2440

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1378-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1377-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12
Z-1378-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12
Z-1379-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12
Z-1380-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12

Product code JWH

K212742Class IIGEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coatingWaldemar Link GmbH & Co. KG / cleared 2021-09-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)