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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann Healing Abutments, Ti

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 Class 2 Device Recall Straumann Healing Abutments, Tisee related information
Date Initiated by FirmSeptember 30, 2026
Date PostedNovember 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0398-2027
Recall Event ID 100097
510(K)NumberK173961 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductStraumann Healing Abutments, Ti, Endosseous Dental Implant Abutments. Article Numbers: 064.4202S, 064.4204S, 064.4214S, 064.8212S, 064.8213S, 064.8215S.
Code Information 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).
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactTodd Shevlin
978-747-2560
Manufacturer Reason
for Recall		Potential exposure to contamination, possibly compromising the sterility and cleanliness.
FDA Determined
Cause 2		Process control
ActionStraumann initially notified consignees starting on 09/30/2026 via telephone calls. Letters were sent to consignees on about 10/02/2026. The letter was used as the script for the initial telephone calls. Consignees were instructed to identify and segregate any affected units on hand, immediately cease use or distribution and quarantine all affected units, return affected units to Straumann for replacement, and complete and return the provided Customer Confirmation form. The notification letter should be passed on to all those who need to be aware within each organization or to any organization where the affected devices have been transferred. Additionally, consignees were advised that if affected units were already implanted/used, implant removal is not required. It was recommended to monitor the patient situation according to clinical judgement and notify Straumann immediately about any adverse health event.
Quantity in Commerce23 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DZE
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