RegWardenFDA facility compliance records
Facility

Riverpoint Medical CR S.R.L.

9 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 1 recalls; 2014: 2 recalls; 2016: 1 recalls; 2018: 1 recalls; 2019: 1 recalls; 2020: 2 recalls; 2023: 1 recalls1’12’132’14’151’16’171’181’192’20’21’221’23’24’25’26
  • Recalls (9)

Devices registered here (1)

  • Fastener, Fixation, Nondegradable, Soft Tissue
    Product code MBI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

Recalls & enforcement

  • Class IIOngoing2023-10-25
    Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to…
  • Class IITerminated2020-12-09
    Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.
  • Class IITerminated2020-08-03
    The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
  • Class IITerminated2019-02-08
    The integrity of the sterile grid packaging is potentially compromised.
  • Class IIITerminated2018-01-09
    Product is labeled with "CE", but is not yet approved in the European Union.
  • Class IITerminated2016-08-05
    Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
  • Class IITerminated2014-09-22
    CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.
  • Class IITerminated2014-04-23
    CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.
  • Class IITerminated2012-12-13
    Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Riverpoint Medical CR S.R.L. (FEI 3027454646) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027454646-riverpoint-medical-cr-s-r-l/

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