Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm

FDA device recall Z-2411-2024 · posted 2024-07-18 · Open, Classified

Recall details

Recalling firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Reason for recall

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

Action taken

LinkBio issue Urgent Medical Device Correction letter to Distributors via email on June 10, 2024. Letter states reason for recall, health risk and action to take: Please take note of the attached modified Surgical Technique for cementing the Tilastan Proximal Tibial Spacer or Proximal Tibial Segment, provided in Appendix A of this notice. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to apply the provided cementing surgical technique for the Tilastan Proximal Tibial Spacer or Proximal Tibial Segment, in case the blind screws are unable to be removed. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions

Root cause

Process design

Status

Open, Classified

Product code

JWH

Quantity affected

114 units US; 2351 units OUS

Distribution

Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Isra

Date initiated

2024-05-22

Date posted

2024-07-18

Location

Norderstedt, Germany

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