Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical s

FDA device recall Z-2054-2012 · posted 2012-07-20 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook, Medium, right).

Action taken

SYNTHES sent a Medical Device Recall letter dated May 31, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees and sales reps remove recalled product from their inventory, call the firm at 1-800-479-6329 to receive an authorization number and complete the enclosed verification form and return to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, Colorado 80132. If customers do not have any of the affected product they were instructed to complete the Verification Section at the end of the letter by checking the appropirate box indicating that no affected porudct has been located. Return the document to Synthes by fax to 610-251-9005 or Scan/Email: FieldAction@synthes.com. For any questions please call 610-719-5450.

Root cause

Employee error

Status

Terminated

Product code

MNI

Quantity affected

12 units

Distribution

Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.

Date initiated

2012-05-31

Date posted

2012-07-20

Date terminated

2015-08-31

Location

West Chester, PA

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