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U.S. Department of Health and Human Services

Class 2 Device Recall LinkSymphoKnee

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 Class 2 Device Recall LinkSymphoKneesee related information
Date Initiated by FirmApril 03, 2025
Date PostedApril 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1699-2025
Recall Event ID 96643
510(K)NumberK202924 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductDistal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 880-303/21 (Sz. 3-4 - cemented lg), (8) 880-303/22 (Sz. 3-4 - cemented x-lg), (9) 880-305/11 (Sz. 5-6 - cemented sm), (10) 880-305/12 (Sz. 5-6 - cemented md), (11) 880-305/21 (Sz. 5-6 - cemented lg), (12) 880-305/22 (Sz. 5-6 - cemented x-lg), (13) 880-307/11 (Sz. 7-8 - cemented sm), (14) 880-307/12 (Sz. 7-8 - cemented md), (15) 880-307/21 (Sz. 7-8 - cemented lg), (16) 880-307/22 (Sz. 7-8 - cemented x-lg), (17) 880-309/11 (Sz. 9-10 - cemented sm), (18) 880-309/12 (Sz. 9-10 - cemented md), (19) 880-309/21 (Sz. 9-10 - cemented lg), (20) 880-309/22 (Sz. 9-10 - cemented x-lg).
Code Information Item Number/UDI-DI: (1) 880-300/11 (04026575284931), (2) 880-300/21 (04026575257102), (3) 880-301/11 (04026575257133), (4) 880-301/21 (04026575257140), (5) 880-303/11 (04026575257171), (6) 880-303/12 (04026575257188), (7) 880-303/21 (04026575257195), (8) 880-303/22 (04026575257201), (9) 880-305/11 (04026575257256), (10) 880-305/12 (04026575257263), (11) 880-305/21 (04026575257270), (12) 880-305/22 (04026575257287), (13) 880-307/11 (04026575257379), (14) 880-307/12 (04026575257386), (15) 880-307/21 (04026575257393), (16) 880-307/22 (04026575257409), (17) 880-309/11 (04026575257454), (18) 880-309/12 (04026575257461), (19) 880-309/21 (04026575257478), (20) 880-309/22 (04026575257485). Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025.
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information ContactJennifer Lubrecht
862-477-0370
Manufacturer Reason
for Recall		The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 in Commerce1180 units
DistributionUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWH
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