FDAClass IIJanuary 21, 2015

Timberline Anchored Lateral Fixed Retractable Sleeve recall

Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the…

Why was Timberline Anchored Lateral Fixed Retractable Sleeve recalled?

The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205

Product
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the…
Recalling firm
Biomet Spine, LLC
Quantity
14 units
Distribution
US Distribution to states of: AZ, CA, NY, TN and TX including PR.
Recall date
January 21, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls