Z-1159-2021Class II

Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO...

Name: Z-1159-2021 Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO...
Creator: ReNovo, Inc.
Published: 2021-01-19
License: https://open.fda.gov/license/

ReNovo, Inc. / initiated 2021-01-19 / Open, Classified / root cause: labeling and UDI

FDA source

ReNovo, Inc. began a recall of Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes... on 2021-01-19. FDA classified it as Class II and gives the reason as "Non-sterile product was shipped to customers labelled as sterile". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1159-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-19
Posted: 2021-03-02
Recalling firm: ReNovo, Inc.
Product: Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.
Product code: HRX Arthroscope
Reason for recall: Non-sterile product was shipped to customers labelled as sterile.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 01/19/2021, an URGENT: Medical Device Recall letter was emailed as well as phone call was made to the three affected customers. The letter states in part: "***Do not use any affected product. All products should be immediately quarantined to prevent unintended use. Please confirm receipt of this notification via phone or email, and Provision will provide a Returned Materials Authorization Number along with pre-paid shipping label. Please ship the affected product back to Provision at your earliest convenience. Please actively monitor patient complaints for symptoms of infection and treat as deemed necessary.***"
Quantity in commerce: 81 units
Distribution: US Nationwide distribution in the states of CA, NJ and OR.
Product codes and lots: Lot Number L-008926-16037 Lot numbers L-008918-16048, and L-008918-16045 Lot numbers L-008936-16275, and L-008933-16078

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1159-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1159-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-10	2021-03-02

Product code HRX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)