FDA Medical Device Recalls (openFDA)
Bock,Otto,Orthopedic Ind,Inc: 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 number
- Z-0537-2010
- Recalling firm
- Bock,Otto,Orthopedic Ind,Inc
- 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.
- Status
- Terminated
- Initiated
- 2008-10-28
- Posted
- 2009-12-16
- Terminated
- 2011-12-10
- Reason
- 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.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 9
- Distribution
- The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.
- Lot, serial or model codes
- Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISY
- Firm FEI
- 2182293
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28