Zimmer Biomet Recall: Incorrect Patient Label on Red Sexp DSTL FEM 19CM RT Assay
Zimmer Biomet recalls Red Sexp DSTL FEM 19CM RT Assay model CP111817 due to potential incorrect patient label in box. This may cause confusion during medical use. No action required as labels are otherwise correct.
Lower-risk recall
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling a specific surgical assembly model because the patient label inside the box might be wrong. This could cause confusion during medical procedures, but the outer box and product itself are correctly labeled. No action is needed since the hazard is minor and only affects labeling. Read more at govinfonow.com/recall/73943-zimmer-biomet-recall-incorrect-patient-label-on-red-sexp-dstl.
Source Summary by GovInfoNow · govinfonow.com/recall/73943-zimmer-biomet-recall-incorrect-patient-label-on-red-sexp-dstl · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0304-2018
Cite this page
“Zimmer Biomet Recall: Incorrect Patient Label on Red Sexp DSTL FEM 19CM RT Assay.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73943-zimmer-biomet-recall-incorrect-patient-label-on-red-sexp-dstl. Based on FDA recall #Z-0304-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0304-2018%22&limit=1).
Why it’s dangerous
The patient label inside the product box could be incorrectly labeled, which might lead to confusion during medical procedures. However, the outer box and the product itself are correctly identified, so the risk is limited to labeling errors.
Who’s affected
Patients using this surgical assembly for medical procedures may be at risk of confusion due to a potential incorrect patient label inside the box. Healthcare providers handling the product are most affected as they rely on accurate labeling.
How to tell if you have this one
Check for the model number CP111817 on the product box and lot number 856460. The product is a surgical assembly called Red Sexp DSTL FEM 19CM RT Assay.
- Brand
Zimmer Biomet- Category
Medical device
All 10 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in US; Internationally Argentina, Netherlands & Canada
| Recall number | Product, codes & lots |
|---|---|
| Z-0296-2018 | Lateral Troch Plate Full Crimp - 254mm, model # 350837; Lot Number: 340530 |
| Z-0297-2018 | Lateral Troch Plate Full Crimp - 254mm, model # 350838; Lot Number: 406590 |
| Z-0298-2018 | COMP 12MM HUM FRAC STEM MACRO, model # 11-113562; Lot Number: 529890 |
| Z-0299-2018 | COMP PRIMARY STEM 8MM MINI, model # 113628; Lot Number: 523080 |
| Z-0300-2018 | ECHO POR FMRL NC 9X125, model # 192009; Lot Number: 410150 |
| Z-0301-2018 | CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064; Lot Number: 854540 |
| Z-0302-2018 | CER BIOLOXD OPTION HD 32MM, model # 650-1056; Lot Number: 843260 |
| Z-0303-2018 | OSS CEMENTED IM STEM 12X150, model # 150366; Lot Number: 71180 |
| Z-0304-2018 | RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817; Lot Number: 856460 |
| Z-0305-2018 | RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828; Lot Number: 856550 |
What to do — step by step
Check Labels
Verify the patient label inside the box matches the outer box and product labels.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide in US; Internationally Argentina, Netherlands & Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0304-2018 (June 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0304-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.