Recalls / —

—#154667

Product

RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)

FDA product code

KDG — Chisel (Osteotome)

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Batch numbers:  431612,452406,455856,463451,472439,472579,483890,485498,494049,495483,4357136940, 4500029102,4500029865,4500032273,4500032667,4500064768,07LSY0010,08BSY0013, 08BSY0015,08FSY0032,08FSY0033,08FSY0033A,08JSY0013,08LSY0009,09BSY0015, 09FSY0007,09HSY0004,09HSY0008,09JSY0004,09JSY0004A,10CSY0009,10CSY0009A, 10CSY0019,10CSY0020,10ESY0016,10HSY0005,10KSY0008,11ASY0011,11BSY0006, 11DSY0004,11DSY0014,11DSY0049,11ESY0008,11FSY0010,11GSY0007,11HSY0010, 11JSY0004,11JSY0012,11MSY0022,12ASY0014,12BSY0019,12CSY0001,12CSY0007,12DSY0016, 12ESY0001,12FSY0028,12GSY0008,12HSY0026,12HSY0042,12KSY0025,12MSY0027,13BSY0008, 13BSY0033,13BSY0042,13DSY0008,13FSY0013,13FSY0024,13JSY0024,13KSY0013,13KSY0014, 13KSY0049,13MSY0007,13MSY0028,14BSY0009,14CSY0031,14CSY0040,14GSY0021,14HSY0012, 14KSY0031,14LSY0013,14LSY0015,15ASY0010,15ASY0016,15BSY0012,15CSY0020,15DSY0014, 15ESY0021,15FSY0025,15GSY0018,15JSY0007,15KSY0024,15MSY0010,16ASY0005,16BSY0011, 16ESY0081,472579A

Why it was recalled

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

Root cause (FDA determination)

Error in labeling

Action the firm took

The firm initiated their recall by email and letter on 03/30/2017. Consignees were asked to inspect inventory to locate and quarantine affected product. All consignees are asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

Timeline

Recall initiated

2017-03-30

Terminated

2019-08-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #154667. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.