Waldemar Link GmbH & Co. KG (Mfg Site): Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7) 880-313/21 (Sz. 3-4 - cemented lg), (8) 880-313/22 (Sz. 3-4 - cemented x-lg), (9) 880-315/11 (Sz. 5-6 - cemented sm), (10) 880-315/12 (Sz. 5-6 - cemented md), (11) 880-315/21 (Sz. 5-6 - cemented lg), (12) 880-315/22 (Sz. 5-6 - cemented x-lg), (13) 880-317/11 (Sz. 7-8 - cemented sm), (14) 880-317/12 (Sz. 7-8 - cemented md), (15) 880-317/21 (Sz. 7-8 - cemented lg), (16) 880-317/22 (Sz. 7-8 - cemented x-lg), (17) 880-319/11 (Sz. 9-10 - cemented sm), (18) 880-319/12 (Sz. 9-10 - cemented md), (19) 880-319/21 (Sz. 9-10 - cemented lg), (20) 880-319/22 (Sz. 9-10 - cemented x-lg).

Recall number

Z-1700-2025

Recalling firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Product

Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7) 880-313/21 (Sz. 3-4 - cemented lg), (8) 880-313/22 (Sz. 3-4 - cemented x-lg), (9) 880-315/11 (Sz. 5-6 - cemented sm), (10) 880-315/12 (Sz. 5-6 - cemented md), (11) 880-315/21 (Sz. 5-6 - cemented lg), (12) 880-315/22 (Sz. 5-6 - cemented x-lg), (13) 880-317/11 (Sz. 7-8 - cemented sm), (14) 880-317/12 (Sz. 7-8 - cemented md), (15) 880-317/21 (Sz. 7-8 - cemented lg), (16) 880-317/22 (Sz. 7-8 - cemented x-lg), (17) 880-319/11 (Sz. 9-10 - cemented sm), (18) 880-319/12 (Sz. 9-10 - cemented md), (19) 880-319/21 (Sz. 9-10 - cemented lg), (20) 880-319/22 (Sz. 9-10 - cemented x-lg).

Status

Open, Classified

Initiated

2025-04-03

Posted

2025-04-30

Terminated

not on file

Reason

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

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 (order@linkbio.com). Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any additional questions.

Quantity

908 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.

Lot, serial or model codes

Item Number/UDI-DI: (1) 880-310/11 (04026575257539), (2) 880-310/21 (04026575257546), (3) 880-311/11 (04026575257607), (4) 880-311/21 (04026575257584), (5) 880-313/11 (04026575257621), (6) 880-313/12 (04026575257645), (7) 880-313/21 (04026575257669), (8) 880-313/22 (04026575257690), (9) 880-315/11 (04026575257768), (10) 880-315/12 (04026575257775), (11) 880-315/21 (04026575257782), (12) 880-315/22 (04026575257799), (13) 880-317/11 (04026575257843), (14) 880-317/12 (04026575257850), (15) 880-317/21 (04026575257867), (16) 880-317/22 (04026575257881), (17) 880-319/11 (04026575257942), (18) 880-319/12 (04026575257959), (19) 880-319/21 (04026575257966), (20) 880-319/22 (04026575257973). Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025.

510(k) numbers

["K202924"]

PMA numbers

not on file

Product code

JWH

Firm FEI

3003386935

Firm city

Norderstedt

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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