Z-0824-2017Class II

DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft...

Name: Z-0824-2017 DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft...
Creator: Stanmore Implants Worldwide Ltd.
Published: 2016-12-07
License: https://open.fda.gov/license/

Stanmore Implants Worldwide, Ltd. / initiated 2016-12-07 / Terminated / root cause: packaging

FDA source

Stanmore Implants Worldwide Ltd. began a recall of DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem... on 2016-12-07. FDA classified it as Class II and gives the reason as "The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem". 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-0824-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-07
Posted: 2016-12-19
Terminated: 2017-07-17
Recalling firm: Stanmore Implants Worldwide, Ltd.
Product: DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Root cause tag: packaging
FDA root cause: Packaging
Action: Stanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations, complete the attached customer response form and list of affected batches form, return the completed form and any affected devices to their S/W Representative. Customers with questions were instructed to contact their local sales representative.
Quantity in commerce: 15 units
Distribution: Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
Product codes and lots: B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0824-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0820-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0821-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0822-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0823-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0824-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19

Product code KRO

K120992Class IIMets Smiles Total Knee ReplacementStanmore Implants Worldwide , Ltd. / cleared 2012-09-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)