Data Foundry

Medical device recalls 2017

RENOVATION — Class II medical device recall Z-1913-2017

Terminated recall by Smith & Nephew, Inc., reported 2017-05-10, distributed nationwide. The stability data does not support the product labeled with a 10-year shelf life.

Recall numberZ-1913-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSmith & Nephew, Inc., Memphis, TN, United States
Recall initiated2017-03-30
Classified2017-05-02
Reported by FDA2017-05-10
Terminated2019-08-21
DistributedNationwide (US)
Countries outside the USAE, AT, AU, BE, CA, CH, CN, CO, CR, DK, EE, ES, FI, FR, GB, IN, IT, JP, MX, NL, NO, PL, RU, SE, SG, TH, TT, VE, ZA
Quantity6,997 units
Reason classeslabeling, specification failure
Lot numbers07LSY0036, 07LSY0039, 08CSY0039, 08CSY0041, 08CSY0052, 08CSY0056, 08JSY0011, 08JSY0014, 08KSY0012, 08LSY0006, 08LSY0048, 08LSY0049, 08MSY0019, 09BSY0008, 09BSY0009, 09BSY0010, 09DSY0011, 09DSY0013, 09FSY0004, 09HSY0001, 09HSY0005.09JSY0001, 10CSY0002, 10CSY0012, 10ESY0007, 10ESY0008, 10ESY0020, 10HSY0008, 11ASY0005, 11ASY0009, 11BSY0005, 11CSY0013, 11DSY0001, 11ESY0005, 11FSY0002, 11GSY0001, 11GSY0018, 11GSY0021, 11HSY0063, 11JSY0002, 12ASY0016 and 57 more
Model numbers71369208

Product

RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)

Reason for recall

The stability data does not support the product labeled with a 10-year shelf life.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1913-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.