FDA Medical Device Recalls (openFDA)
ZIMMER ORTHOPEDIC MFG LTD: NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
- Recall number
- Z-0663-2018
- Recalling firm
- ZIMMER ORTHOPEDIC MFG LTD
- Product
- NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
- Status
- Terminated
- Initiated
- 2017-07-24
- Posted
- not on file
- Terminated
- 2018-04-16
- Reason
- There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
- Root cause
- Reprocessing Controls
- Action
- On approximately July 24, 2017, customers were notified via letter of the recall. Instructions for distributors included to ensure affected personnel are aware of the recall, locate and quarantine any affected product in inventory, complete and return the Inventory Return Certification Form, make arrangements to return the product Zimmer Biomet, and provide customers if product was further distributed. Instructions for Risk Managers at medical facilities include to ensure affected personnel are aware of the recall, to assist the Zimmer Biomet sales representative in identifying and quarantining affected devices so they can be removed by the sales representative, and to complete and return the Certification of Acknowledgement form. Further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. or 1 (800) 613-6131
- Quantity
- 7 devices
- Distribution
- Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.
- Lot, serial or model codes
- Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)
- 510(k) numbers
- not on file
- PMA numbers
- ["P060037"]
- Product code
- NJL
- Firm FEI
- 3007963827
- Firm city
- Shannon
- Firm state
- not on file
- Firm country
- Ireland
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