FDA Medical Device Recalls (openFDA)
Endotec, Inc.: "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 7.5mm CAT 04-33-0031; SIZE 2 x 7.5mm CAT 04-33-0032; SIZE 3 x 7.5mm CAT 04-33-0033; SIZE 4 x 7.5mm CAT 04-33-0034; SIZE 5 x 7.5mm CAT 04-33-0035; SIZE 6 x 7.5mm CAT 04-33-0036. Tricompartmental Knee Replacement
- Recall number
- Z-0434-2012
- Recalling firm
- Endotec, Inc.
- Product
- "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 7.5mm CAT 04-33-0031; SIZE 2 x 7.5mm CAT 04-33-0032; SIZE 3 x 7.5mm CAT 04-33-0033; SIZE 4 x 7.5mm CAT 04-33-0034; SIZE 5 x 7.5mm CAT 04-33-0035; SIZE 6 x 7.5mm CAT 04-33-0036. 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
- 243
- Distribution
- USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
- Lot, serial or model codes
- 04330031Z001NN434 K04330031A1NN701 K04330031A2NN702 K04330032A1NN720 04330032Z001NN444 K04330032Z1001NN453 K04330033A1NN720 K04330033Z001NN450 K04330034A1NN703 04330034Z001NN442 04330035HNN398 04330035JNN398 04330036HNN338 04330036GNN321 04330036FNN309 04330036GNN400 04330036HNN400
- 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