CLASS II Device recall · Reported 8 Jan 2014 · FDA Enforcement Report
Itst Threaded Guide Pin recalled by Zimmer
Zimmer is recalling Itst Threaded Guide Pin. The recall was initiated on 5 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0589-2014
- FDA event ID
- 66499
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2013
- FDA classified
- 27 Dec 2013
- Reported
- 8 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 5 Nov 2013 | Recall initiated by company | |
| 27 Dec 2013 | Classified by FDA | +52 days |
| 8 Jan 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ITST THREADED GUIDE PIN
Where it was distributed
Worldwide Distribution.
Questions about this recall
Is Itst Threaded Guide Pin recalled?
Yes. Zimmer recalled Itst Threaded Guide Pin on 5 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0589-2014.
Why was it recalled?
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
Which lots are affected?
Item Numbers: 47-2258-067-00 All Lots with an expiration date prior to July 24, 2023
Where was it sold?
Worldwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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