L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3)

FDA device recall Z-1701-2025 · posted 2025-04-30 · Open, Classified

Recall details

Recalling firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

JWH

Quantity affected

441 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.

Date initiated

2025-04-03

Date posted

2025-04-30

Location

Norderstedt, Germany

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