FDA Medical Device Recalls (openFDA)
Endotec, Inc.: "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X7.5 CAT 04-63-2133; SIZE 3-4X7.5 CAT 04-63-2134; SIZE 3-5X7.5 CAT 04-63-2135; SIZE 3-6X7.5 CAT 04-63-2136. Tricompartmental Knee Replacement
- Recall number
- Z-0439-2012
- Recalling firm
- Endotec, Inc.
- Product
- "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X7.5 CAT 04-63-2133; SIZE 3-4X7.5 CAT 04-63-2134; SIZE 3-5X7.5 CAT 04-63-2135; SIZE 3-6X7.5 CAT 04-63-2136. Tricompartmental Knee Replacement
- Status
- Terminated
- Initiated
- 2011-09-21
- Posted
- 2012-01-11
- Terminated
- 2013-09-27
- Reason
- On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
- Root cause
- PMA
- Action
- Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
- Quantity
- 68
- Distribution
- USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
- Lot, serial or model codes
- LOT #'S 04632133ANN172, 04632134BNN249, 04632135BNN249, 04632136ANN172.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NRA
- Firm FEI
- 3004553437
- Firm city
- Orlando
- Firm state
- FL
- 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