Food, drugs, devices › Biomet, Inc.
Device recall: Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
FDA enforcement event 89544 is a device recall by Biomet, Inc. of Warsaw, IN, initiated 7 Jan 2022 and classified Class II, with 8 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 13 Apr 2023. Initiation: voluntary: firm initiated. Biomet, Inc. has 84 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Biomet, Inc., Warsaw, IN.
Reason for recall
"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…"
Distribution
"Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0670-2022 | Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301 | 19 units | Class II | Terminated | 2 Mar 2022 |
| Z-0671-2022 | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611 | 10 units | Class II | Terminated | 2 Mar 2022 |
| Z-0672-2022 | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614 | 12 units | Class II | Terminated | 2 Mar 2022 |
| Z-0673-2022 | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618 | 12 units | Class II | Terminated | 2 Mar 2022 |
| Z-0674-2022 | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631 | 11 units | Class II | Terminated | 2 Mar 2022 |
| Z-0675-2022 | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632 | 12 units | Class II | Terminated | 2 Mar 2022 |
| Z-0676-2022 | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633 | 9 units | Class II | Terminated | 2 Mar 2022 |
| Z-0677-2022 | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635 | 11 units | Class II | Terminated | 2 Mar 2022 |
Context
Other enforcement events for Biomet, Inc.
All 84 events for Biomet, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Apr 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.