FDA Medical Device Recalls (openFDA)
Zimmer Manufacturing B.V.: NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
- Recall number
- Z-0590-2016
- Recalling firm
- Zimmer Manufacturing B.V.
- Product
- NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
- Status
- Terminated
- Initiated
- 2015-12-03
- Posted
- 2016-01-05
- Terminated
- 2016-09-15
- Reason
- A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3.
- Root cause
- Labeling mix-ups
- Action
- Zimmer Biomet sent an "Urgent Medical Device Recall-Lot Specific" letter to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to do the following: Review the notification and ensure affected personnel are aware of the contents. 2. Locate all affected product identified above and quarantine them immediately. 3. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1). Email a completed copy of Attachment 1 to corporatequality.postmarket@zimmer.com. 4. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 1). Clearly mark the outside carton of each product return shipment made as Recall. 5. Please notify Zimmer Biomet of any hospitals to which you have further distributed the affected product. Supply the information for any hospitals that you have identified, as well as the affected surgeons, using the provided spreadsheet template. The template will be emailed to you for completion. Please return to corporate quality.postmarket@zimmerbiomet.com. 6. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.
- Quantity
- 384 distribution events; 1 unit was returned leaving 383 units .
- Distribution
- Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.
- Lot, serial or model codes
- lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)
- 510(k) numbers
- ["K933785"]
- 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