Z-1548-2013Class II

Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder...

Name: Z-1548-2013 Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder...
Creator: Biomet, Inc.
Published: 2013-05-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-05-15 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain on 2013-05-15. FDA classified it as Class II and gives the reason as "Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1548-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Posted: 2013-06-17
Terminated: 2014-06-09
Recalling firm: Zimmer GmbH
Product: Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Product code: PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Reason for recall: Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.
Root cause tag: design
FDA root cause: Device Design
Action: On 5/15/2013 an URGENT MEDICAL DEVICE RECALL notification was sent to all consignees detailing to immediately locate and discontinue use of the product and return to Biomet. The following actions are REQUIRED: -Immediately locate and remove the identified device(s) listed below from circulation . -Carefully follow the instructions on the enclosed "FAX Back Response Form" . -Fax a copy of the Response Form to 574-372-1683 prior to return of product. -Use priority carrier for your shipment. - If you have further distributed this product. you MUST notify hospital personnel of this action via the enclosed "Dear O.R. Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices.
Quantity in commerce: 17
Distribution: Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.
Product codes and lots: Catalog number: 010001814 and lot numbers: 318520 and 644720.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1548-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1548-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-17

Product code PAO

K080642Class IIComprehensive Reverse ShoulderBiomet, Inc. / cleared 2008-07-09

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)