NA 72202931Recalls & reported problems
Smith & Nephew, Inc. · ANKLE STABILIZATION KITS, DISPOSABLE 6 UNITS · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885554018288), received between Nov 23, 2018 and Nov 23, 2018 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Expiration Date Error” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Expiration Date Error5
Patient problems
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 23, 2018Expiration Date Error
IT WAS REPORTED THAT WHEN THE PATIENT WAS ALREADY ASLEEP THEY WENT TO OPEN THE INVASIVE ANKLE STRAPS (CAME IN WITH THE LOAN) AND NOTICED THAT THEY WENT OUT OF DATE IN MAY 2017. THEY HAVE NOW HAD TO WAKE THE PATIENT UP AND WILL HAVE TO RESCHEDULE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8100054 ↗MalfunctionNov 23, 2018Expiration Date Error
IT WAS REPORTED THAT WHEN THE PATIENT WAS ALREADY ASLEEP THEY WENT TO OPEN THE INVASIVE ANKLE STRAPS (CAME IN WITH THE LOAN) AND NOTICED THAT THEY WENT OUT OF DATE IN (B)(6) 2017. THEY HAVE NOW HAD TO WAKE THE PATIENT UP AND WILL HAVE TO RESCHEDULE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8100034 ↗MalfunctionNov 23, 2018Expiration Date Error
IT WAS REPORTED THAT WHEN THE PATIENT WAS ALREADY ASLEEP THEY WENT TO OPEN THE INVASIVE ANKLE STRAPS (CAME IN WITH THE LOAN) AND NOTICED THAT THEY WENT OUT OF DATE IN (B)(6) 2017. THEY HAVE NOW HAD TO WAKE THE PATIENT UP AND WILL HAVE TO RESCHEDULE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8100025 ↗MalfunctionNov 23, 2018Expiration Date Error
IT WAS REPORTED THAT WHEN THE PATIENT WAS ALREADY ASLEEP THEY WENT TO OPEN THE INVASIVE ANKLE STRAPS (CAME IN WITH THE LOAN) AND NOTICED THAT THEY WENT OUT OF DATE IN MAY 2017. THEY HAVE NOW HAD TO WAKE THE PATIENT UP AND WILL HAVE TO RESCHEDULE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8099989 ↗MalfunctionNov 23, 2018Expiration Date Error
IT WAS REPORTED THAT WHEN THE PATIENT WAS ALREADY ASLEEP THEY WENT TO OPEN THE INVASIVE ANKLE STRAPS (CAME IN WITH THE LOAN) AND NOTICED THAT THEY WENT OUT OF DATE IN MAY 2017. THEY HAVE NOW HAD TO WAKE THE PATIENT UP AND WILL HAVE TO RESCHEDULE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8099978 ↗
Other EXPANDER, SURGICAL, SKIN GRAFT devices
- N/A 00-7701-000-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft521 reports
- N/A 00-7703-015-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft206 reports
- N/A 00-7703-020-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft103 reports
- MeshgraftTM II Tissue Expansion System 00-2195-013-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft1 recall30 reports
- MESHGRAFT™ 00-2195-000-00Zimmer Orthopaedic Surgical Products, Inc. · EXPANDER, SURGICAL, SKIN GRAFT41 reports
- N/A 00-7703-030-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft33 reports
- N/A 00-7703-040-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft27 reports
- MESHGRAFT™ 00-2195-001-00Zimmer Orthopaedic Surgical Products, Inc. · EXPANDER, SURGICAL, SKIN GRAFT25 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.