Waldemar Link Posterior Femoral Augment Recall: Missing Thread Screw Hazard
Waldemar Link recalls Posterior Femoral Augment implants with missing thread screws. These devices may not function properly during surgery. Affected items have specific item numbers and sizes.
Lower-risk recall
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Contact the company
What happened, in plain English
Waldemar Link is recalling certain Posterior Femoral Augment implants because they were delivered with a preassembled screw that lacks its thread. This defect could cause the implant to fail during surgery, potentially leading to complications for patients. Read more at govinfonow.com/recall/52496-waldemar-link-posterior-femoral-augment-recall-missing-thread-screw-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/52496-waldemar-link-posterior-femoral-augment-recall-missing-thread-screw-hazard · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1700-2025
Cite this page
“Waldemar Link Posterior Femoral Augment Recall: Missing Thread Screw Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52496-waldemar-link-posterior-femoral-augment-recall-missing-thread-screw-hazard. Based on FDA recall #Z-1700-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1700-2025%22&limit=1).
Why it’s dangerous
The implant screws were delivered without their threads, meaning they cannot securely attach to the bone. This defect could cause the implant to loosen or fail during surgery, potentially requiring additional procedures or causing complications.
Who’s affected
Patients who received the recalled Posterior Femoral Augment implants (item numbers 880-310/11 to 880-319/22) manufactured up to March 1, 2025, are affected. Surgeons and medical facilities using these implants are at risk of complications during procedures.
How to tell if you have this one
Check the item number on the implant packaging or label. The affected models have specific sizes (0-10) and cemented versions (small, medium, large, extra-large). The recall covers all units manufactured up to March 1, 2025.
- Brand
Waldemar Link- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1699-2025 | Distal 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).; 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. | 1180 units |
| Z-1700-2025 | 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).; 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. | 908 units |
| Z-1701-2025 | L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented lg).; Item Number/UDI-DI: (1) 880-320/12 (04026575258048), (2) 880-320/22 (04026575258055), (3) 880-321/12 (04026575258062), (4) 880-321/22 (04026575258079), (5) 880-323/13 (04026575258086), (6) 880-323/23 (04026575258109), (7) 880-325/13 (04026575258123), (8) 880-325/23 (04026575258147), (9) 880-327/13 (04026575258154), (10) 880-327/23 (04026575258161), (11) 880-329/13 (04026575258178), (12) 880-329/23 (04026575258185). Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025. | 441 units |
| 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 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);; 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. | 1771 units |
What to do — step by step
Contact Manufacturer
Reach out to Waldemar Link directly to confirm if your implant is affected and get instructions for next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Missouri, Nevada, Ohio, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the implant immediately?
The recall does not require immediate discontinuation; contact Waldemar Link to determine if your implant is affected and follow their guidance.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1700-2025 (April 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1700-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.