The Recall Desk
SevereFDA (Devices)·Z-1699-2025·Announced 2025-05-07

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.

What this means for you

Illness, injury, or structural failure has been reported. 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) 88
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic implant
Hazard
  • manufacturing-defect
  • device-failure

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

Distributed nationwide across the United States.

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