DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x3

FDA device recall Z-0824-2017 · posted 2016-12-19 · Terminated

Recall details

Recalling firm

Stanmore Implants Worldwide Ltd.

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.

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

KRO

Quantity affected

15 units

Distribution

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Date initiated

2016-12-07

Date posted

2016-12-19

Date terminated

2017-07-17

Location

Borehamwood, Centennial, United Kingdom

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