Z-1702-2025Class II

Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented...

Name: Z-1702-2025 Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2025-04-03
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2025-04-03 / Open, Classified / root cause: manufacturing process

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4)... on 2025-04-03. FDA classified it as Class II and gives the reason as "The device was delivered with a preassembled Femoral Augment screw that was missing its thread". 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-1702-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-03
Posted: 2025-04-30
Recalling firm: Waldemar Link GmbH & Co. KG
Product: Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7) 880-333/11 (Sz. 3-4 - cemented x-sm), (8) 880-333/12 (Sz. 3-4 - cemented sm), (9) 880-333/13 (Sz. 3-4 - cemented md), (10) 880-333/21 (Sz. 3-4 - cemented lg), (11) 880-333/22 (Sz. 3-4 - cemented x-lg), (12) 880-333/23 (Sz. 3-4 - cemented xx-lg), (13) 880-335/11 (Sz. 5-6 - cemented x-sm), (14) 880-335/12 (Sz. 5-6 - cemented sm), (15) 880-335/13 (Sz. 5-6 - cemented md), (16) 880-335/21 (Sz. 5-6 - cemented lg), (17) 880-335/22 (Sz. 5-6 - cemented lg), (18) 880-335/23 (Sz. 5-6 - cemented xx-lg), (19) 880-337/11 (Sz. 7-8 - cemented x-sm), (20) 880-337/12 (Sz. 5-6 - cemented sm), (21) 880-337/13 (Sz. 7-8 - cemented md), (22) 880-337/21 (Sz. 7-8 - cemented lg), (23) 880-337/22 (Sz. 7-8 - cemented x-lg), (24) 880-337/23 (Sz. 7-8 - cemented xx-lg), (25) 880-339/11 (Sz. 9-10 - cemented x-sm), (26) 880-339/12 (Sz. 9-10 - cemented sm), (27) 880-339/13 (Sz. 9-10 - cemented md), (28) 880-339/21 (Sz. 9-10 - cemented lg), (29) 880-339/22 (Sz. 9-10 - cemented x-lg), (30) 880-339/23 (Sz. 9-10 - cemented xx-lg);
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On April 3, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were emailed to customers. Actions to be taken by the Customer/User: Please take note of the following instructions for replacing any screws found missing the thread. No product return is required. Instructions for disassembling and replacing a defective screw: Disassembly 1. Use the 2.5 mm Torque Wrench article REF (15-2545) to unscrew the screw from the Augment while pushing the tip of the screw towards the Augment. 2. Exchange the screw. Open an alternative Augment and use its screw. Alternative sizes of Augments are always available in the operating room during the surgery. For all Femoral Augment sizes and types the same long screw type is preassembled and for all Tibial Augments the same short screw type is preassembled, see table 1. Assembly/Replacement 3. Use the 2.5 mm Torque Wrench article REF (15-2545) to screw in the replacement screw into the Augment. 4. The screw head must be countersunk in the Augment and the screw tip must protrude. Follow the LinkSymphoKnee surgical technique for all other steps. Please respond using the Distributor Reply form to indicate your understanding of this Device Correction and of the need to apply the instructions provided above to replace any affected screws. Type of Action by the Company: LINK will provide sterilized replacement screws (for both Femoral Augments and Tibial Augments) for each affected distributor as a back-up for upcoming surgeries. Other Information: Opening an additional Augment to exchange the screw will not incur any costs to you. Should you have any questions about acquiring backup/replacement screws for forthcoming surgeries (once available), please contact Customer Service at LinkBio ([email protected]). Please contact LinkBio at 973-625-1333 or [email protected] for any additional questions.
Quantity in commerce: 1771 units
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
Product codes and lots: Item Number/UDI-DI: (1) 880-331/11 (04026575258192), (2) 880-331/12 (04026575258208), (3) 880-331/13 (04026575258215), (4) 880-331/21 (04026575258222), (5) 880-331/22 (04026575258246), (6) 880-331/23 (04026575258253), (7) 880-333/11 (04026575258260), (8) 880-333/12 (04026575258277), (9) 880-333/13 (04026575258284), (10) 880-333/21 (04026575258291), (11) 880-333/22 (04026575258307), (12) 880-333/23 (04026575258314), (13) 880-335/11 (04026575258321), (14) 880-335/12 (04026575258338), (15) 880-335/13 (04026575258345), (16) 880-335/21 (04026575258352), (17) 880-335/22 (04026575258369), (18) 880-335/23 (04026575258376), (19) 880-337/11 (04026575258383), (20) 880-337/12 (04026575258390), (21) 880-337/13 (04026575258406), (22) 880-337/21 (04026575258413), (23) 880-337/22 (04026575258420), (24) 880-337/23 (04026575258437), (25) 880-339/11 (04026575258475), (26) 880-339/12 (04026575258505), (27) 880-339/13 (04026575258529), (28) 880-339/21 (04026575258536), (29) 880-339/22 (04026575258543), (30) 880-339/23 (04026575258550); Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1702-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1699-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-30
Z-1700-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-30
Z-1701-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-30
Z-1702-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-30

Product code JWH

K202924Class IILinkSymphoKnee SystemWaldemar Link GmbH & Co. KG / cleared 2021-05-13

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)