Moderate riskFDA DeviceNov 9, 2026Class II

Straumann BLC healing abutments recalled for possible contamination

Straumann USA LLC is recalling eight article numbers of BLC dental implant healing abutments (WB Healing Abutment, O6, GH1.5, AH2, Ti). The notice says these may have been exposed to contamination, which could compromise sterility and cleanliness. No injuries have been reported, and 33 units were distributed in 25 states.

From the FDA notice · Read the official notice ↗ · All Straumann recalls

What to do

Set aside any affected units and do not place them in patients.
Check lot numbers, UDIs and RFID tags against the article numbers and lots listed in the notice.
Contact Straumann USA LLC about affected units; the notice does not specify a remedy.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Straumann BLC Implants, SLActive, RXD. Endosseous Dental Implant. WB Healing Abutment, O6, GH1.5, AH2,Ti. Article Numbers: 035.9208S, 035.9210S, 035.9214S, 035.9408S, 035.9412S, 035.9414S, 035.9708S, 035.9710S.
Sold in: US distribution to AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA.
Made for: All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 33 units
Illnesses reported: None reported
Manufactured in: 60 Minuteman Rd, Andover, Massachusetts, United States
Classification: Class II
Recall number: Z-0397-2027

In the FDA's words

Description: Straumann BLC Implants, SLActive, RXD. Endosseous Dental Implant. WB Healing Abutment, O6, GH1.5, AH2,Ti. Article Numbers: 035.9208S, 035.9210S, 035.9214S, 035.9408S, 035.9412S, 035.9414S, 035.9708S, 035.9710S. Potential exposure to contamination, possibly compromising the sterility and cleanliness. 1. Article Number: 035.9208S. UDI: (01)07630031764287(11)260113(17)310112(10)WTHZ1. Lot Number WTHZ1. RFID Tags: 3268A29802041025242818C9, 3268A29802041025242818CA, 3268A29802041025242818FD. 2. Article Number: 035.9210S. UDI: (01)07630031764294(11)260324(17)310323(10)YCYH5. Lot Number YCYH5. RFID Tags: 3268A29802041025242817FD. 3. Article Number: 035.9214S. UDI: (01)07630031764317(11)260316(17)310315(10)YCYJ5. Lot Number YCYJ5. RFID Tags: 3268A29802041025242819E6, 3268A29802041025242819E8. 4. Article 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). 5. Article Number: 035.9412S. UDI: (01)07630031764447(11)260312(17)310311(10)YEEX9. Lot Number YEEX9. RFID Tags: 3268A29802041025242818DB. 6. Article Number: 035.9414S. UDI: (01)07630031764454(11)250910(17)300909(10)PNTV7. Lot Number PNTV7. RFID Tags: 3268A298020410252428193E. 7. Article Number: 035.9708S. UDI: (01)07630031764553(11)260309(17)310308(10)XZWZ9. Lot Number XZWZ9. RFID Tags: 3268A2980204102524281825. 8. Article 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). Distribution: US distribution to AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA. Affected quantity: 33 units
Hazard: Potential exposure to contamination, possibly compromising the sterility and cleanliness.

2 products in this recall

Straumann healing abutments recalled for possible contamination

Straumann is recalling 2 dental healing abutment products, with 56 units affected: Straumann BLC Implants SLActive WB Healing Abutments and Straumann Healing Abutments, Ti. The recall is for potential exposure to contamination, which may compromise sterility and cleanliness. The notice reports no injuries.

The agency lists each product separately. Check every one you might have.

Straumann BLC Implants, SLActive, RXD. Endosseous Dental Implant. WB Healing Abutment, O6, GH1.5, AH2,Ti. Article Numbers: 035.9208S, 035.9210S, 035.9214S, 0… (this page)
Z-0397-2027 · 33 units
Straumann Healing Abutments, Ti, Endosseous Dental Implant Abutments. Article Numbers: 064.4202S, 064.4204S, 064.4214S, 064.8212S, 064.8213S, 064.8215S.
Z-0398-2027 · 23 units