| | Class 2 Device Recall Straumann BLC Implants |  |
| Date Initiated by Firm | September 30, 2026 |
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| Date Posted | November 09, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0397-2027 |
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| Recall Event ID |
100097 |
| 510(K)Number | K230108 |
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| Product Classification |
Implant, endosseous, root-form - Product Code DZE
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| 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. |
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| Code Information |
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). |
| FEI Number |
1000121052
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Recalling Firm/
Manufacturer |
Straumann USA LLC
60 Minuteman Rd
Andover
MA
01810-1008
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| For Additional Information Contact | Todd Shevlin
978-747-2560 |
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Manufacturer Reason
for Recall | Potential exposure to contamination, possibly compromising the sterility and cleanliness. |
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FDA Determined
Cause 2 | Process control |
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| Action | Straumann 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. |
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| Quantity in Commerce | 33 units |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = DZE
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