FDA Medical Device Recalls (openFDA)
Zimmer Manufacturing B.V.: Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total knee arthroplasty
- Recall number
- Z-1146-2016
- Recalling firm
- Zimmer Manufacturing B.V.
- Product
- Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total knee arthroplasty
- Status
- Terminated
- Initiated
- 2016-01-11
- Posted
- 2016-03-12
- Terminated
- 2017-04-13
- Reason
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Root cause
- Packaging
- Action
- Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
- Quantity
- 0
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- lot no.: 61873094 61895696 61905916 61905918 61905920 61919766 61919767 61919768 61956249 61956250 61981202 61981204 61999375 62027331 62060784 62074467 62074469 62096750 62096751 62133740 62164984 62168517 62171693 62171694 62171696 62174936 62205101 62213332 62213333 62220943 62345691 62345692 62345693 62345694 62352447 62352450
- 510(k) numbers
- ["K960279"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000132037
- Firm city
- Mercedita
- Firm state
- not on file
- Firm country
- PR
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