In the agency's Nov 18, 2026 enforcement report · Ongoing
Straumann BLC Implants, SLActive, RXD. Endosseous Dental Implant. WB Healing Abutment, O6, GH1.5, AH2,Ti. Article…
Straumann USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Straumann USA LLC · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- Straumann BLC Implants, SLActive, RXD. Endosseous Dental Implant. WB Healing Abutment, O6, GH1.5, AH2,Ti
- Article Numbers
035.9208S035.9210S035.9214S035.9408S035.9412S035.9414S035.9708S035.9710S
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Barcodes Product as published — 07630031764287Article Number: 035.9208S. UDI: (01)07630031764287(11)260113(17)310112(10)WTHZ1. Lot Number WTHZ1. RFID Tags: 3268A29802041025242818C9, 3268A29802041025242818CA, 3268A29802041025242818FD. — 07630031764294Article Number: 035.9210S. UDI: (01)07630031764294(11)260324(17)310323(10)YCYH5. Lot Number YCYH5. RFID Tags: 3268A29802041025242817FD. — 07630031764317Article Number: 035.9214S. UDI: (01)07630031764317(11)260316(17)310315(10)YCYJ5. Lot Number YCYJ5. RFID Tags: 3268A29802041025242819E6, 3268A29802041025242819E8. — 07630031764423076300317644230763003176442307630031764423Article Number: 035.9408S. UDI: (01)07630031764423(11)260619(17)310618(10)AGKLT, (01)07630031764423(11)260110(17)310109(10)WPMJ1, (01)07630031764423(11)260210(17)310209(10)XHRL4, (01)07630031764423(11)260224(17)310223(10)XXVC7. Lot Number (RFID Tag): AGKLT (3268A298020403252424EDCC), WPMJ1 (3268A298020401252421BE79), XHRL4 (3268A29802032625241E6651, 3268A29802032625241E6655), XXVC7 (3268A298020410252428194D, 3268A298020410252428195A). — 07630031764447Article Number: 035.9412S. UDI: (01)07630031764447(11)260312(17)310311(10)YEEX9. Lot Number YEEX9. RFID Tags: 3268A29802041025242818DB. TV7.07630031764454Article Number: 035.9414S. UDI: (01)07630031764454(11)250910(17)300909(10) Lot Number PNTV7. RFID Tags: 3268A298020410252428193E. — 07630031764553Article Number: 035.9708S. UDI: (01)07630031764553(11)260309(17)310308(10)XZWZ9. Lot Number XZWZ9. RFID Tags: 3268A2980204102524281825. — 0763003176456007630031764560Article Number: 035.9710S. UDI: (01)07630031764560(11)260610(17)310609(10)AFJEW, (01)07630031764560(11)251220(17)301219(10)VFVF8. Lot Number (RFID Tags): AFJEW (3268A298020331252420B549, 3268A298020403252424EDCA), VFVF8 (3268A29802041025242817E8, 3268A298020410252428192A, 3268A2980204102524281992, 3268A2980204102524281996, 3268A2980204102524281998, 3268A298020410252428199A, 3268A298020410252428199B, 3268A298020410252428199D, 3268A298020410252428199E, 3268A298020410252428199F, 3268A29802041025242819A5, 3268A29802041025242819A7, 3268A29802041025242819A8, 3268A29802041025242819AB, 3268A29802041025242819AE, 3268A29802122624004BF15E). - Amount recalled
- 33 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential exposure to contamination, possibly compromising the sterility and cleanliness.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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