Use caution Medical device recall · FDA · Published January 7, 2022

Biomet Shoulder Stem Recall: Risk of Poor Adhesion After Waterjet Rework

Biomet recalls certain shoulder stem implants due to potential poor adhesion from improper waterjet rework. Affected items may not stay securely attached, risking complications after surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0671-2022Medical device Biomet ›

Use caution until it’s fixed

The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

Take action

Contact the company

Recalling firmBiomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989

✎ GovInfoNow plain-language explainer

Biomet is recalling specific shoulder stem implants that may have poor adhesion due to an incorrect rework process. This could lead to the implant loosening or failing after surgery, which is serious for patients who have had the procedure. Read more at govinfonow.com/recall/61294-biomet-shoulder-stem-recall-risk-of-poor-adhesion-after-waterjet.

Source Summary by GovInfoNow · govinfonow.com/recall/61294-biomet-shoulder-stem-recall-risk-of-poor-adhesion-after-waterjet · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0671-2022

Cite this page

“Biomet Shoulder Stem Recall: Risk of Poor Adhesion After Waterjet Rework.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61294-biomet-shoulder-stem-recall-risk-of-poor-adhesion-after-waterjet. Based on FDA recall #Z-0671-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0671-2022%22&limit=1).

The FDA announced on Jan. 7, 2022, that Biomet, Inc. is recalling one lot of Comprehensive Shoulder System Primary Shoulder Stems due to insufficient coating adhesion strength. The agency classified the recall as Class II.

How to tell if you have it

Biomet
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long
Item Number: 113611
Lot Number: 821170
UPC: 00880304554122

The hazard

Internal testing indicated that the porous plasma sprayed coating on the stems may not have sufficient adhesion strength. The hazard stems from an incorrect rework operation where parts were recoated at a vendor and then processed through an internal waterjet rework process not validated for such products.

Context

GovInfoNow's records show Biomet, Inc. has had 28 other recalls on record since Feb. 28, 2018. Recent brand recalls include the July 1, 2026 Intramedullary Bone Saw Blade Recall for sterile packaging risk and the Sept. 23, 2025 ZipT recall for a missing button assembly. Other recent recalls of similar products include the May 20, 2026 Zimmer Off-Axis Shoulder System Recall and the July 30, 2026 Howmedica TRIATHLON Hinge Insert Recall.

How to tell if you have this one

Check for the item number 113611 and lot number 821170 on the implant. The recall covers all implants with this specific model that were reworked through the internal waterjet process.

Brand
Biomet
Product
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
Category
Medical device

FDA recall event · 8 products

All 8 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
Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.

Recall number	Product, codes & lots	Quantity
Z-0670-2022	Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301; Lot Number: 853650, 853810 UDI: (01)00880304468030(17) 290122(10)853650; (01)00880304468030(17) 290211(10)853810	19 units
Z-0671-2022	Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611; Lot Number: 821170 UDI: (01)00880304554122(17) 280825(10)821170	10 units
Z-0672-2022	Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614; Lot Number: 439470 UDI: (01)00880304554153(17) 290803(10)439470	12 units
Z-0673-2022	Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618; Lot Number: 732370 UDI: (01)00880304554191(17) 290802(10)732370	12 units
Z-0674-2022	Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631; Lot Number: 821860 UDI: (01)00880304462687(17) 290522(10)821860	11 units
Z-0675-2022	Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632; Lot Number: 327160 UDI: (01)00880304449749(17)290819(10)327160	12 units
Z-0676-2022	Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633; Lot Number: 994800 UDI:(01)00880304462632(17)290816(10)994800	9 units
Z-0677-2022	Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635; Lot Number: 396250 UDI: (01)00880304462663(17)281121(10)396250	11 units

Based on the official FDA remedy

What to do — step by step

Check Implant Details
Look for the item number 113611 and lot number 821170 on the implant to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.” 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 15 months after the firm started it.

Jan 7, 2022Firm started the recall
Feb 24, 2022FDA classified it Class II
Mar 2, 2022Published in FDA’s Enforcement Report
Apr 13, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this implant?

No, the recall does not require immediate removal. Patients should check if their implant matches the affected model and lot numbers and contact Biomet for further guidance.

What should I do if I have this implant?

Contact Biomet directly to confirm if your implant is affected and follow their instructions for next steps.

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Link to this recall

<a href="https://govinfonow.com/recall/61294-biomet-shoulder-stem-recall-risk-of-poor-adhesion-after-waterjet">Biomet Shoulder Stem Recall: Risk of Poor Adhesion After Waterjet Rework (GovInfoNow)</a>

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-0671-2022 (January 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0671-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.