Z-2297-2016Class II

SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total...

Name: Z-2297-2016 SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total...
Creator: Smith & Nephew, Inc.
Published: 2016-07-06
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-07-06 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals... on 2016-07-06. FDA classified it as Class II and gives the reason as "The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2297-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-06
Posted: 2016-07-28
Terminated: 2017-07-01
Recalling firm: Smith & Nephew, Inc.
Product: SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Smith & Nephew sent an Urgent Product Recall Notification letter dated July 6, 2016, to all affected consignees via email and FedEx Overnight delivery on July 6, 2016. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were asked to inspect their inventory and located any unused affected devices and quarantine them immediately, complete the Inventory Return Certification Form and fax to 1-901-566-7975 indicating the quantities that need to be returned. Consignees should contact Smith & Nephew's Field Actions Department via email at [email protected] to obtain a return authorization (RA) number. For questions regarding this recall call 901-399-5520.
Quantity in commerce: 185 units
Distribution: Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR
Product codes and lots: Lot Number 16AM14274

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2297-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2297-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-28

Product code MEH

K990666Class IIHydroxyapatite (Ha) Reflection Acetabular Shell, Hydroxyapatite (Ha) Reflection Interfit ShellSmith & Nephew, Inc. / cleared 1999-08-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)