In short
- Most records concern labelling, packaging mix-ups, components or instruments, not a design fault of an implant system.
- A recall of one reference or batch does not mean 'Straumann implants are unsafe'.
- If you're worried, ask your clinic for your implant's lot number and check with them.
Straumann-branded records
| Recall no. | Initiated | Product | Reason (FDA wording, shortened) | Status |
|---|---|---|---|---|
| Z-2935-2026 | 2026-07-16 | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); impl | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm | Open, Classified |
| Z-1994-2026 | 2026-03-27 | Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant | Includes an incorrect screw seat interface. | Open, Classified |
| Z-1995-2026 | 2026-03-27 | Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments | Includes an incorrect screw seat interface. | Open, Classified |
| Z-1632-2026 | 2026-03-17 | Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; | A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701 | Open, Classified |
| Z-1633-2026 | 2026-03-17 | Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; | A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701 | Open, Classified |
| Z-1337-2026 | 2026-01-06 | WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM | The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. | Open, Classified |
| Z-1671-2025 | 2025-04-17 | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | Incorrect blister labelling. | Open, Classified |
| Z-1861-2025 | 2025-04-14 | Plus Initial Drill, Article Number: 103.170; | The referred batch was produced without the laser engraving of 7 mm. | Open, Classified |
| Z-1561-2025 | 2025-03-08 | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; | The devices are missing the laser marked depth markings. | Open, Classified |
| Z-2336-2021 | 2021-06-25 | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as m | Product label intended for the European community was distributed to the USA market via their US distribution organization | Open, Classified |
| Z-2198-2021 | 2021-05-27 | Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. denta | Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and c | Terminated |
| Z-0957-2017 | 2016-11-23 | Straumann Drill 1, short, 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 | Drills cannot be inserted into handpiece due to tolerance specification not met | Terminated |
| Z-0958-2017 | 2016-11-23 | Straumann Twist Drill PRO 4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 | Drills cannot be inserted into handpiece due to tolerance specification not met | Terminated |
| Z-2534-2016 | 2016-07-14 | Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510 | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration | Terminated |
| Z-2535-2016 | 2016-07-14 | Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512 | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration | Terminated |
| Z-0981-2015 | 2014-10-27 | Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental im | Drill set may contain incorrect drill. | Terminated |
| Z-0174-2015 | 2014-09-24 | Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 | Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) | Terminated |
| Z-0117-2015 | 2014-09-19 | Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308 Denta | Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) | Terminated |
| Z-2161-2012 | 2012-07-11 | Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.26 | Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2 | Terminated |
| Z-1351-2012 | 2012-03-12 | Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are inte | Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN | Terminated |
| Z-3184-2011 | 2011-08-04 | Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement | Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position pla | Terminated |
| Z-1592-2011 | 2010-09-30 | Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0 | Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve. | Terminated |
| Z-2177-2010 | 2010-06-15 | Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in | The label on the tubular packaging for the Straumann Impression set f. WN solid abutment has the incorrect description of RN solid abutment instead of | Terminated |
| Z-0320-2011 | 2009-06-04 | Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use as a drilling guide t | Incorrect Inner diameter of the T-sleeve | Terminated |
| Z-1876-2008 | 2008-05-28 | Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Produ | Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to pati | Terminated |
| Z-1037-2008 | 2008-01-10 | Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, M | Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures | Terminated |
| Z-0277-2008 | 2007-09-28 | Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC, Andover, Massachuset | Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical | Terminated |
| Z-0278-2008 | 2007-09-28 | Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachuset | Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical f | Terminated |
| Z-0840-06 | 2006-03-30 | Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043 | The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top | Terminated |
| Z-0602-06 | 2006-01-30 | Thermoplastic templates, single tooth Catalog Number: 040.526 | Pilot drills may not fully extend through drill guide in template products | Terminated |
| Z-0603-06 | 2006-01-30 | Thermoplastic templates, free-end situation Catalog Number: 040.527 | Pilot drills may not fully extend through drill guide in template products | Terminated |
| Z-0975-05 | 2005-06-06 | RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560 | Basal screw is too short to adequately hold the dental abutment in the implant | Terminated |
| Z-0300-05 | 2004-11-11 | Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: | Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN) | Terminated |
| Z-1035-04 | 2004-05-21 | Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044 | Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN) | Terminated |
Source: FDA device recall database via openFDA.1 Wording shortened; see the FDA record for full details.
How to read this
- Check the exact product and reference. Most notices concern a specific article or lot.
- 'Terminated' means the FDA considers the recall completed.
- Recall counts cannot be used to rank brands: larger manufacturers sell more products and report more notices.
Would you like a dentist to assess whether this treatment suits you?
Request an assessment
Clinical review pending. Facts on this page are checked against the sources listed below (regulatory records, manufacturer documents, peer-reviewed research). A named clinician will review it before we call it medically reviewed.
Last updated 28 Sep 2026 · How we review
Last updated 28 Sep 2026 · How we review
Sources
- Regulatory recordopenFDA: device recall records with recalling firm 'Straumann' — U.S. Food and Drug Administration. Accessed 28 Sep 2026.
Educational information only. The choice of implant system depends on your anatomy, restorative plan, bone quality and the clinician's assessment. This website does not recommend a specific implant for you.
