In the agency's Nov 18, 2026 enforcement report · Ongoing
Straumann Healing Abutments, Ti, Endosseous Dental Implant Abutments. Article Numbers: 064.4202S, 064.4204S, 064.4214S,…
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 Healing Abutments, Ti, Endosseous Dental Implant Abutments
- Article Numbers
064.4202S064.4204S064.4214S064.8212S064.8213S064.8215S
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 07630031738387Article Number: 064.4202S. UDI: (01)07630031738387(11)260409(17)310408(10)ZCFL7. Lot Number: ZCFL7. RFID Tags: 3268A2980204102524281922, 3268A2980204102524281915. 2 07630031738400Article Number: 064.4204S. UDI: (01)07630031738400(11)260415(17)310414(10)ZEKR7. Lot Number: ZEKR7. RFID Tags: 3268A298020401252421C2A7, 3268A2980204102524281916, 3268A2980204102524281917. 3 076300317384480763003173844807630031738448Article 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 0763003173855407630031738554Article 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 07630031738561Article Number: 064.8213S. UDI: (01)07630031738561(11)260414(17)310413(10)YZEW5. Lot Number: YZEW5. RFID Tags: 3268A29802122624004BF154, 3268A29802122624004BF162. 6 0763003173992607630031739926Article 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). - Amount recalled
- 23 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.
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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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