Food, drugs, devices › Smith & Nephew, Inc.
Device recall: Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Smith & Nephew, Inc. (Mansfield, MA) initiated this device recall on 11 Dec 2017; FDA lists 1 product record under event 79700, 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 21 Sep 2020. Initiation: voluntary: firm initiated. Smith & Nephew, Inc. has 107 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
Smith & Nephew, Inc., Mansfield, MA.
Reason for recall
"Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed."
Distribution
"Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1536-2018 | Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 | 22 | Class II | Terminated | 2 May 2018 |
Context
Other enforcement events for Smith & Nephew, Inc.
All 107 events for Smith & Nephew, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed."
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: "Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 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.