—#164626

Product

Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162

FDA product code: NXT — Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P040033
Affected lot / code info: (a) Size 56 mm, REF 74120156, Lot 16CW01824 (b) Size 64 mm, REF 74120164, Lot 16DW10975 (c) Size 54 mm, REF 74122154, Lot 16BW17747 (d) Size 58 mm, REF 74122158, Lot 16CW16199 (e) Size 60 mm, REF 74122160, Lot 08GW18001B (f) Size 62 mm, REF 74122162, Lot 16CW20851

Why it was recalled

The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US

Root cause (FDA determination)

Process control

Action the firm took

The firm initiated the recall by email and letter on 05/11/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: OH, TX, CO, TN, MI, PA, NJ

Timeline

Recall initiated: 2018-05-11
Posted by FDA: 2018-05-21
Terminated: 2019-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164626. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.