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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86597

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 25, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stryker GmbH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Osteosynthesis Compression Staple EasyClip

Z-0457-2021
Recall number
Z-0457-2021
Initiated
September 25, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Stryker GmbH
Quantity
121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.

Code information

All lots of the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress are affected. Exp. Date: 5 years from date of manufacturing EasyClip and EasyClip Xpress staples are available in a variety of sizes identified by product and catalog numbers. See below: Product Number Product Description EZ15-12-12 Osteosynthesis Compression Staple EasyClip 15x12x12mm EZ15-15-15 Osteosynthesis Compression Staple EasyClip 15x15x15mm EZ18-12-12 Osteosynthesis Compression Staple EasyClip 18x12x12mm EZ18-15-13 Osteosynthesis Compression Staple EasyClip 18x15x13mm EZ18-14-14 Osteosynthesis Compression Staple EasyClip 18x14x14mm EZ18-17-15 Osteosynthesis Compression Staple EasyClip 18x17x15mm EZ18-19-17 Osteosynthesis Compression Staple EasyClip 18x19x17mm EZ20-16-16 Osteosynthesis Compression Staple EasyClip 20x16x16mm EZ20-20-20 Osteosynthesis Compression Staple EasyClip 20x20x20mm EZ25-22-22 Osteosynthesis Compression Staple EasyClip 25x22x22mm EZB10-15-13 Osteosynthesis Compression Staple EasyClip 10x15x13mm EZB10-17-15 Osteosynthesis Compression Staple EasyClip 10x17x15mm EZB10-19-16 Osteosynthesis Compression Staple EasyClip 10x19x16mm EZB10-20-17 Osteosynthesis Compression Staple EasyClip 10x20x17mm EZB12-15-13 Osteosynthesis Compression Staple EasyClip 12x15x13mm EZB10-22-20 Osteosynthesis Compression Staple EasyClip 10x22x20mm EZB12-17-15 Osteosynthesis Compression Staple EasyClip 12x17x15mm EZB12-19-16 Osteosynthesis Compression Staple EasyClip 12x19x16mm EZM08-08-08 Osteosynthesis Compression Staple EasyClip 8x8x8mm EZM10-10-10 Osteosynthesis Compression Staple EasyClip 10x10x10mm EZM12-10-10 Osteosynthesis Compression Staple EasyClip 10x10x10mm EZM12-14-14 Osteosynthesis Compression Staple EasyClip 12x14x14mm EZM12-16-16 Osteosynthesis Compression Staple EasyClip 12x16x16mm Catalog # Product EZBXP10-15-13 EasyClip Xpress 10x15x13 EZBXP12-15-13 EasyClip Xpress 12x15x13 EZMXP08-08-08 EasyClip Xpress 08x08x08 EZMXP10-10-10 EasyClip Xpress 10x10x10 EZMXP12-10-10 EasyClip Xpress 12x10x10 EZXP15-12-12 EasyClip Xpress 15x12x12 EZXP15-15-15 EasyClip Xpress 15x15x15 EZXP18-14-14 EasyClip Xpress 18x14x14 EZXP18-17-15 EasyClip Xpress 18x17x15 EZXP18-19-17 EasyClip Xpress 18x19x17 EZXP20-16-16 EasyClip Xpress 20x16x16 EZXP20-20-20 EasyClip Xpress 20x20x20 EZXP25-22-22 EasyClip Xpress 25x22x22

Distribution pattern

The devices were distributed nationwide throughout the US, and to countries OUS. Easy Clip devices: As of 09/04/2020, 251,566 EasyClip devices have been manufactured. 121,517 of those devices were distributed to the US, and 102,529 were distributed in countries OUS. 27,520 devices were left in the firm's inventory. Easy Clip Xpress devices: As of 09/04/2020, 37,371 EasyClip Xpress devices have been manufactured. 9,561 of those devices were distributed to the US, leaving 27,810 in the firm's inventory. This device is only distributed in the United States.

Field note

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