Food, drugs, devices › Stryker Sustainability Solutions
Device recall: Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut
Stryker Sustainability Solutions (Tempe, AZ) initiated this device recall on 27 Jul 2018; FDA lists 1 product record under event 82063, classified Class II.
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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 17 Sep 2020. Initiation: voluntary: firm initiated. Stryker Sustainability Solutions has 36 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
Stryker Sustainability Solutions, Tempe, AZ.
Reason for recall
"Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used."
Distribution
"Nationwide Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and Puerto…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0973-2019 | Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures… | 14,265 units | Class II | Terminated | 13 Mar 2019 |
Context
Other enforcement events for Stryker Sustainability Solutions
All 36 events for Stryker Sustainability Solutions
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used."
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: "Nationwide Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and Puerto…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Sep 2020. "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.