Distal Femoral Augment medical device recall for defective screw
Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class II FDA recall of an orthopedic implant with a structural manufacturing defect (missing thread on preassembled screw) that compromises device function and could result in implant failure, loosening, or the need for surgical intervention. Although no illnesses or injuries are reported in the source text, the defect directly affects a critical component of a load-bearing surgical implant, meeting the Severe criteria.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices (multiple item numbers and sizes) distributed nationwide. The devices were delivered with a preassembled femoral augment screw that was missing its thread, which could compromise the integrity and proper function of the implant.
A total of 1,180 units have been distributed across 17 U.S. states: Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Illinois, Kansas, Louisiana, Maryland, Missouri, Nevada, Ohio, Texas, Virginia, and Wisconsin. All lots of the LINK SymphoKnee Femoral Augments listed were affected, manufactured up until March 1, 2025.
Patients who have received this device should contact their healthcare provider or the manufacturer immediately. Healthcare providers should cease use of any affected devices and contact Waldemar Link GmbH & Co. KG for further guidance on removal or replacement.
The recalled product
- Product
- 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)…
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 1,180
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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)
- manufactured up until 03/01/2025.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)
See all →- HighWaldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets
FDA (Devices) · 2026-08-19
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- HighLink Endo-Model plateau 15-0027/15 recalled over screw bushing fracture
FDA (Devices) · 2026-03-18
- HighLink Endo-Model SL component 16-2840/05 recalled over bushing fracture
FDA (Devices) · 2026-03-18
Same hazard · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- HighLinkSymphoKnee Knee Augment Recalled for Incorrect Screw Orientation
FDA (Devices) · 2023-07-12
- HighLinkSymphoKnee Distal Femoral Augment Recalled for Improper Screw Placement
FDA (Devices) · 2023-07-12
- ModerateZimmer NexGen Augment Recalled for Missing Locking Screw
FDA (Devices) · 2015-05-13
- HighKnee Prosthesis Femoral Segment Recalled Due to Specification Compliance Issue
FDA (Devices) · 2023-07-05
- ModerateZimmer Biomet Recalls Vanguard Distal Femoral Augments Due to Labeling Error
FDA (Devices) · 2016-10-26
- HighLINK SymphoKnee System Femoral Augment Recalled for Incorrect Implant in Packaging
FDA (Devices) · 2023-06-07