Medium RiskFDA Device

Smith & Nephew, Inc.: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

Agency Publication Date: April 18, 2017

Affected Products

Product: Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic

Batch 15HM05197

Lot Numbers:

15HM05197

Product: D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic

Batch number 15KM05493

Lot Numbers:

number

Product: D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic

Batch number 14MM07780R

Lot Numbers:

number

Product: D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424

Batch numbers: (a) RES 74692410: 15GM13481, 15JM17474, 15JM17475 (b) RES 74692412: 15EM010131, 15JM07539 (c) RES 74692416: 15FM06118 (d) RES 74692422: 16AM19135 (e) RES 74692424: 15JM19559

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76729

Status: Resolved

Manufacturer: Smith & Nephew, Inc.

Manufactured In: United States

Units Affected: 4 products (1 unit; 19 units; 100 units; 197 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic

Batch 15HM05197

Lot Numbers:

15HM05197

Product: D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic

Batch number 15KM05493

Lot Numbers:

number

Product: D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic

Batch number 14MM07780R

Lot Numbers:

number

Batch numbers: (a) RES 74692410: 15GM13481, 15JM17474, 15JM17475 (b) RES 74692412: 15EM010131, 15JM07539 (c) RES 74692416: 15FM06118 (d) RES 74692422: 16AM19135 (e) RES 74692424: 15JM19559

Lot Numbers:

numbers