FDA Medical Device Recalls (openFDA)
Straumann USA LLC: GM Helix Implant, REF: 109.984;
- Recall number
- Z-3173-2026
- Recalling firm
- Straumann USA LLC
- Product
- GM Helix Implant, REF: 109.984;
- Status
- Open, Classified
- Initiated
- 2026-08-12
- Posted
- 2026-09-15
- Terminated
- not on file
- Reason
- There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Root cause
- Under Investigation by firm
- Action
- On August 12, 2026, Urgent Field Safety Action letters were sent to customers. Actions to be taken: 1. Identify and segregate any units in your stock with carton packaging labeled as Article 109.984 Helix GM Implant, 4.0 x 11.5 mm, L ot VZPF4 2. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. 3. Please return the affected items to the attention of Todd Shevlin at Straumann USA, LLC for replacement as indicated on the Customer Confirmation Form. 4. If the product has already been implanted, implant removal is not required, and no additional patient follow -up is required solely due to this recall 5. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC. If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to todd.shevlin@straumann.com
- Quantity
- 216
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;
- Lot, serial or model codes
- REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
- 510(k) numbers
- ["K163194"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1000121052
- Firm city
- Andover
- Firm state
- MA
- 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