Bock, Otto, Orthopedic Ind, Inc Two Carlson Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. Pediatric Prosthetic Device used by Lower Limb amputees. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. Pediatric Prosthetic Device used by Lower Limb amputees.
Brand
Bock, Otto, Orthopedic Ind, Inc Two Carlson
Lot Codes / Batch Numbers
Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.
Products Sold
Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.
Bock, Otto, Orthopedic Ind, Inc Two Carlson is recalling Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstad due to Otto Bock Health Care LP has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. This can cause . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Otto Bock Health Care LP has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. This can cause the axes to gradually move out of the joint and result in a risk of falling for the user.
Recommended Action
Per FDA guidance
Consignees were sent on 10/28/08 a Otto Bock "Urgent: Correction Notice" letter dated October 27, 2008. The letter described the product and problem. It provided instructions if the product was in stock and instructed the consignee to contact the patients (a patient letter was provided) and to complete and return the reply card. Consignees were to contact Otto Bock at their Customer Service to request a return authorization.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026