FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
- Recall number
- Z-0906-2015
- Recalling firm
- Exactech, Inc.
- Product
- Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
- Status
- Terminated
- Initiated
- 2014-10-09
- Posted
- 2015-01-05
- Terminated
- 2016-06-08
- Reason
- Mislabeled
- Root cause
- Labeling mix-ups
- Action
- The firm, Exactech, sent an "Urgent Field Safety Notice" letter dated September 30, 2014 to its Consignees/customers by electronic mail on October 9, 2014. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately cease distribution or use of the products; extend information to your accounts that may have this product in their possession; verify whether you have any of the subject femoral components from the specified serial number ranges; complete and return the attached inventory RESPONSE FORM via fax to: 011 61 2 9638 0778 within 48 hrs of receipt of the notice, and contact your Exactech representative to confirm quantities at your location and arrangements for product return and inventory restocking. If you have any questions, contact Manager, Regulatory Affairs at 352-377-1140.
- Quantity
- 96
- Distribution
- International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
- Lot, serial or model codes
- Catalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.
- 510(k) numbers
- ["K033883"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1038671
- Firm city
- Gainesville
- 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