Moderate riskFDA DeviceNov 9, 2026Class II

Straumann titanium healing abutments recalled for contamination risk

Straumann USA LLC is recalling six article numbers of titanium healing abutments for dental implants. The abutments may have been exposed to contamination, which could compromise their sterility and cleanliness. The notice reports 23 units, distributed to 25 states, and no injuries.

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

What to do

Set aside affected healing abutments and do not use them on patients.
Check article numbers 064.4202S, 064.4204S, 064.4214S, 064.8212S, 064.8213S and 064.8215S against the UDI, lot number and RFID tag listed in the notice.
The notice doesn't specify a remedy; contact Straumann USA LLC for return or replacement instructions.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Straumann Healing Abutments, Ti, Endosseous Dental Implant Abutments. Article Numbers: 064.4202S, 064.4204S, 064.4214S, 064.8212S, 064.8213S, 064.8215S.
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: Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 23 units
Illnesses reported: None reported
Manufactured in: 60 Minuteman Rd, Andover, Massachusetts, United States
Classification: Class II
Recall number: Z-0398-2027

In the FDA's words

Description: Straumann Healing Abutments, Ti, Endosseous Dental Implant Abutments. Article Numbers: 064.4202S, 064.4204S, 064.4214S, 064.8212S, 064.8213S, 064.8215S. Potential exposure to contamination, possibly compromising the sterility and cleanliness. 1. Article Number: 064.4202S. UDI: (01)07630031738387(11)260409(17)310408(10)ZCFL7. Lot Number: ZCFL7. RFID Tags: 3268A2980204102524281922, 3268A2980204102524281915. 2. Article Number: 064.4204S. UDI: (01)07630031738400(11)260415(17)310414(10)ZEKR7. Lot Number: ZEKR7. RFID Tags: 3268A298020401252421C2A7, 3268A2980204102524281916, 3268A2980204102524281917. 3. Article Number: 064.4214S. UDI: (01)07630031738448(11)260630(17)310629(10)AGANV, (01)07630031738448(11)260307(17)310306(10)XWNH6, (01)07630031738448(11)260430(17)310429(10)ZHFW1. Lot Number (RFID Tag): AGANV (3268A29802032525241D74EF, 3268A2980203282524207407, 3268A29802032625241E664A, 3268A29802032725241FD42B, 3268A29802032625241E6649), XWNH6 (3268A29802041025242818FA, 3268A29802041025242818DF), ZHFW1 (3268A29802032625241E2932). 4. Article Number: 064.8212S. UDI: (01)07630031738554(11)260217(17)310216(10)XTYP7, (01)07630031738554(11)260511(17)310510(10)ZNZT4. Lot Number (RFID Tags): XTYP7 (3268A298020410252428196A), ZNZT4 (3268A29802032625241E6648, 3268A29802041025242818DF). 5. Article Number: 064.8213S. UDI: (01)07630031738561(11)260414(17)310413(10)YZEW5. Lot Number: YZEW5. RFID Tags: 3268A29802122624004BF154, 3268A29802122624004BF162. 6. Article Number: 064.8215S. UDI: (01)07630031739926(11)260302(17)310301(10)XWWW2, (01)07630031739926(11)260422(17)310421(10)ZFGP9. Lot Number (RFID Tags): XWWW2 (3268A2980204102524281898, 3268A29802041025242818ED, 3268A298020410252428191A, 3268A298020410252428191D), ZFGP9 (3268A29802032725241FD437). 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: 23 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…
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. (this page)
Z-0398-2027 · 23 units