CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report
Posterior Femoral Augment recalled by Waldemar Link GmbH & Co. KG
Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Posterior Femoral Augment, distributed nationwide in the US. The recall was initiated on 3 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1700-2025
- FDA event ID
- 96643
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Apr 2025
- FDA classified
- 30 Apr 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 3 Apr 2025 | Recall initiated by company | |
| 30 Apr 2025 | Classified by FDA | +27 days |
| 7 May 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Product as listed by the FDA
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).
Where it was distributed
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIllinoisIndianaKansasLouisianaMarylandMissouriNevadaOhioTexasVirginiaWisconsin
Questions about this recall
Why was it recalled?
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 96643| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tibial Augment recalled by Waldemar Link GmbH & Co. KG | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide | |
| CLASS II | Distal Femoral Augment recalled by Waldemar Link GmbH & Co. KG | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide | |
| CLASS II | L-Shaped Femoral Augment recalled by Waldemar Link GmbH & Co. KG | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
More recalls from Waldemar Link GmbH & Co. KG (Mfg Site)
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | Embrace Drill Tower, Standard/Lateral recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | 15 states |
| Device | CLASS II | Embrace Drill Tower, Wedged recalled by Waldemar Link GmbH & Co. KG | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | 15 states |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-0027/16 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-0027/12 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |