Biomet Sports Medicine Anchor Devices and Ziploop Constructs

510(k) K080088

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK080088	Date11 Jun 2008Cleared	StatusActive

8 recalls · FDA

- Terminated Z-1364-2015 FDA Class II initiated 26 Feb 2015 on shared 510(k) K080088
The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
7 recalls, same reason
- Terminated Z-1237-2012 FDA Not yet classified initiated 25 Jan 2012
- Terminated Z-1233-2012 FDA Not yet classified initiated 25 Jan 2012
- Terminated Z-1232-2012 FDA Not yet classified initiated 25 Jan 2012
- Terminated Z-1234-2012 FDA Not yet classified initiated 25 Jan 2012
- Terminated Z-1236-2012 FDA Not yet classified initiated 25 Jan 2012
- Terminated Z-1235-2012 FDA Not yet classified initiated 25 Jan 2012
- Terminated Z-1231-2012 FDA Not yet classified initiated 25 Jan 2012
Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications, Contraindications, Possible Adverse Effects, and some Warnings are not present with the packaged device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)